Drugs / Neratinib
Neratinib
also known as
HKI-272 · neratinib maleate · CDP-820 · Neratinib maleate anhydrous · Neratinib Maleate Tablets · Nerlynx · WAY-179272
Small molecule targets EGFR, ERBB2, ERBB4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 5 milestones | |||||
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2019-09-11 | “the filing of the new drug application for neratinib in the metastatic breast cancer indication” pumabiotechnology.com ↗ “FDA has accepted for review its supplemental New Drug Application (sNDA) for neratinib” pumabiotechnology.com ↗ |
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2019-07-01 | “has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib” pumabiotechnology.com ↗ |
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2016-09-20 | “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in July for neratinib for the extended adjuvant treatment” pumabiotechnology.com ↗ “Puma Biotechnology announced on September 20, 2016 that the FDA had accepted for filing the NDA for neratinib.” pumabiotechnology.com ↗ |
| Filed | EU (EMA) | — | Her2-receptor negative breast cancer | 2016-06-27 | “announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib.” pumabiotechnology.com ↗ |
| Filed | Other | NERLYNX | Her2-receptor negative breast cancer | — | “Puma Biotechnology filed a new drug submission for NERLYNX® with Health Canada in July 2018” pumabiotechnology.com ↗ |
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | EU (EMA) | — | progesterone-receptor positive breast cancer | 2016-08-22 | “Puma Biotechnology announced on August 22, 2016 that the MAA for neratinib had been validated by the EMA.” pumabiotechnology.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (4) | US (FDA) | NERLYNX | — | 2019-10-01 – 2021-06-28 | fda.gov ↗ |
| Approved | EU (EMA) | Nerlynx | — | 2018-08-31 | europa.eu ↗ |
| Approved | US (FDA) | NERLYNX | — | 2017-07-17 | fda.gov ↗ |
| Filed | US (FDA) | — | HER2-overexpressed/amplified early-stage breast cancer | 2016-07-21 | “has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib)” pumabiotechnology.com ↗ |
Trials 86 · started per year
today
US approved 2017
EU approved 2018
1
1
4
3
6
9
4
1
2
5
2
2
3
4
3
2
5
4
9
5
8
3
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06008275 | Sep 2024 → Jun 2026 overdue | triple-negative breast carcinoma | Baylor Research Institute | Recruiting | No outcome recorded |
| Phase 125 trials | ||||||
| Phase 1 | NCT05372614 | Oct 2022 → Jul 2028 expected | metastatic malignant neoplasm, pancreatic adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05274048 | Jun 2022 → Jun 2027 expected | gastric cancer | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04502602 | Aug 2020 → Oct 2024 overdue | ovarian cancer | Virginia Commonwealth University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03065387 | Oct 2017 → Oct 2028 expected | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02593708 | Nov 2015 → Jan 2017 | cancer | Michelle Melisko | Terminated | No outcome recorded |
| Phase 1 | NCT02334501 | Aug → Oct 2014 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00932464 | Aug 2012 | — | Puma Biotechnology, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01423123 | May 2011 → Aug 2012 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 1 | NCT01128842 | Apr 2010 → Mar 2011 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00958724 | Jul 2009 → Apr 2010 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00781430 | Apr 2009 → Feb 2010 | liver disorder | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00838539 | Apr 2009 → Jun 2011 | carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00864487 | Apr → May 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00860223 | Apr 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00814060 | Jan → Mar 2009 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00768469 | Oct 2008 → Jan 2011 | cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00757809 | Oct 2008 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00708903 | May → Jul 2008 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00550212 | Mar → Apr 2008 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00498745 | Jul → Sep 2007 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00397046 | Nov 2006 → Mar 2009 | neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00380328 | Oct → Nov 2006 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00366600 | Jul → Dec 2006 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00146172 | Nov 2003 → Jan 2007 | breast neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/212 trials | ||||||
| Phase 1/2 | NCT05243641 | Aug 2022 → Nov 2024 | breast cancer, metastatic neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03919292 | May 2019 → Dec 2029 | cancer | Virginia Commonwealth University | Suspended | No outcome recorded |
| Phase 1/2 | NCT03101748 | Feb 2018 → May 2025 | inflammatory breast carcinoma, metastatic carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03377387 | Dec 2017 → Dec 2026 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02932280 | Oct 2016 → Oct 2026 expected | central nervous system neoplasm, leukemia, lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02236000 | Aug 2014 → Dec 2020 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT01960023 | Oct 2013 → Jul 2016 | colorectal cancer | NSABP Foundation Inc | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01111825 | Apr 2010 → Jul 2016 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00741260 | Dec 2008 → Nov 2010 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00706030 | Apr 2008 → Oct 2009 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00445458 | Sep 2007 → May 2011 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00398567 | Apr 2007 → Jul 2009 | breast cancer | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 242 trials · 6 missed | ||||||
| Phase 2 | NCT07333937 | Dec 2025 → Nov 2027 expected | breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07152782 | Sep 2025 → Aug 2029 expected | HER2 positive breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT05933395 | Sep 2024 → Oct 2030 expected | breast cancer | Dartmouth-Hitchcock Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06519110 | Aug 2024 → Feb 2026 overdue | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05919108 | May 2024 → Apr 2030 expected | invasive lobular breast carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06126276 | May 2024 → Feb 2027 expected | female reproductive organ cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06374888 | Apr 2024 → Sep 2026 overdue | gastroesophageal adenocarcinoma | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06109467 | Jan 2024 → Mar 2028 expected | gastric cancer, gastroesophageal cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06029816 | Nov 2023 → Dec 2024 | non-small cell lung carcinoma | Convalife (Shanghai) Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04901299 | Jul 2023 → Jul 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, invasive breast carcinoma, progesterone-receptor positive breast cancer | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05388149 | Dec 2022 → Jul 2026 overdue | HER2 positive breast carcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT04965064 | Sep 2022 → Sep 2026 overdue | breast cancer | University of Rochester | Recruiting | No outcome recorded |
| Phase 2 | NCT05512182 | Sep 2022 → Oct 2023 | — | Yonsei University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05252988 | Aug 2022 → Oct 2024 overdue | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04886531 | Jul 2022 → Dec 2026 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | Ruth O'Regan | Recruiting | No outcome recorded |
| Phase 2 | NCT05154396 | Jan 2022 → Dec 2023 | HER2 positive breast carcinoma | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT04856475 | Nov 2021 | breast cancer, metastatic malignant neoplasm in the brain | Jules Bordet Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT04760431 | Oct 2021 → Sep 2024 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT06083662 | Jun 2021 → Nov 2023 | metastatic malignant neoplasm | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04781374 | May → Sep 2021 | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma | Beth Israel Deaconess Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04460430 | Jul 2020 → Nov 2021 | breast cancer | SOLTI Breast Cancer Research Group | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04366713 | Jun 2020 → Dec 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04374305 | Jun 2020 → Dec 2029 expected | NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma | Scott R. Plotkin, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT03812393 | Jun 2019 → Dec 2024 | HER2 positive breast carcinoma, female breast carcinoma, triple-negative breast carcinoma | West Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT03094052 | Oct 2018 → Oct 2022 | HER2 positive breast carcinoma, breast adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT03457896 | May 2018 → Sep 2021 | colorectal cancer | NSABP Foundation Inc | Unknown | No outcome recorded |
| Phase 2 | NCT03289039 | Oct 2017 → Jul 2021 | breast cancer | Dana-Farber Cancer Institute | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT02977780 | Feb 2017 → Feb 2028 expected | glioblastoma | Patrick Wen, MD | Recruiting | Missed primary |
| Phase 2 | NCT03182634 | Dec 2016 → Nov 2022 | female breast carcinoma | Institute of Cancer Research, United Kingdom | Unknown | Mixed |
| Phase 2 | NCT02673398 | Dec 2016 → Mar 2020 | HER2 positive breast carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02400476 | Feb 2015 → Apr 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01953926 | Sep 2013 → Jan 2023 | — | Puma Biotechnology, Inc. | Terminated | Missed primary |
| Phase 2 | NCT01827267 | Jul 2013 → Sep 2016 | carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01670877 | Dec 2012 → Feb 2021 | breast neoplasm | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01008150 | Oct 2010 → Sep 2015 | breast cancer | NSABP Foundation Inc | Completed | Missed primary |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2 | NCT00915018 | Aug 2009 → Aug 2013 | breast cancer | Puma Biotechnology, Inc. | Completed | Missed primary |
| Phase 2 | NCT00777101 | Feb 2009 → Mar 2011 | breast cancer | Puma Biotechnology, Inc. | Completed | Missed primary |
| Phase 2 | NCT00300781 | Aug 2006 → Apr 2008 | breast neoplasm | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00266877 | Dec 2005 → Jan 2009 | non-small cell lung carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05760612 | Mar 2023 → Feb 2028 expected | HER2 positive breast carcinoma, female breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT01808573 | Mar 2013 → Sep 2018 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00878709 | Jul 2009 → Aug 2014 | breast cancer | Puma Biotechnology, Inc. | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06015113 | Sep 2023 → Apr 2026 overdue | breast cancer | Xi'an International Medical Center Hospital | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01956253 | Jul → Sep 2013 | urinary bladder cancer | UNC Lineberger Comprehensive Cancer Center | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT07153952 Comparator | Jan 2025 → Jan 2027 expected | cervical adenosquamous carcinoma | Peking Union Medical College Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01494662 Comparator | Feb 2012 → Feb 2023 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 89
| Date | Issuer | Release |
|---|---|---|
| 2022-12-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented updated findings from the Translational Breast Cancer Research Consortium (TBCRC) Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas. |
| 2022-10-27 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022 EORTC/NCI/AACR Symposium pumabiotechnology.com ↗
The interim efficacy results showed that the objective response rate (ORR) was 35% overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs. |
| 2022-09-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib for HER2-Mutant, Recurrent/Metastatic Cervical Cancer at the ESMO Congress 2022 pumabiotechnology.com ↗
Overall, the objective response rate was 18.2% (95% CI: 5.2–40.3%) and the clinical benefit rate was 45.5% (95% CI: 24.4–67.8%), which included 1 patient with a confirmed complete response, 3 patients with confirmed partial responses, and 6 patients with stable disease at equal or greater than 16 weeks. |
| 2022-06-06 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Outcomes from the Metastatic Breast Cancer Cohort of the SUMMIT Trial at the ASCO 2022 Annual Meeting pumabiotechnology.com ↗ |
| 2022-06-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Final Results from the Biliary Tract Cohort of the Phase 2 SUMMIT ‘Basket’ Trial of Neratinib at the ASCO 2022 Annual Meeting pumabiotechnology.com ↗ |
| 2021-12-10 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updates from the SUMMIT Trial at the 2021 SABCS Annual Meeting ◼ Neratinib in combination with fulvestrant and trastuzumab offers promising results for patients with hormone receptor-positive, HER2-mutated metastatic breast cancer with prior exposure to CDK4/6 inhibitors ◼ Neratinib in combination with trastuzumab results in strong activity in patients with triple negative metastatic breast cancer with a HER2 mutation pumabiotechnology.com ↗ |
| 2021-11-20 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Data from the Neratinib Arm of the INSIGhT Trial at the 2021 SNO Annual Meeting pumabiotechnology.com ↗
For the neratinib arm of the trial, there were 149 patients in the intent-to-treat population, including 81 patients treated with neratinib and 68 patients in the control arm. |
| 2021-07-06 | Knight Therapeutics (USA) Inc | Regulatory Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer knighttx.com ↗ |
| 2021-07-01 | Puma Biotechnology, Inc. | Regulatory FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer Dose escalation of NERLYNX therapy demonstrated improved management and prevention of Grade 3 diarrhea pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU. |
| 2021-06-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Data from the EGFR Exon 18-mutant NSCLC Cohort of the Phase II SUMMIT Trial at the 2021 ASCO Annual Meeting Neratinib efficacy evidenced in patients with EGFR exon 18-mutant non-small cell lung cancer and CNS involvement pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented interim results from the Phase II SUMMIT basket trial, assessing the efficacy of neratinib in patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC), including patients with central nervous system (CNS) involvement, at the virtual 2021 ASCO Annual Meeting. |
| 2021-06-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Data from the Phase III ExteNET Trial in Early Stage HER2-Positive Breast Cancer Patients at the Virtual 2021 ASCO Annual Meeting Results show improved outcomes in overall survival in patients with HER2-positive early stage breast cancer who received ≥ 11 months of treatment with neratinib pumabiotechnology.com ↗ |
| 2021-06-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Data Comparing Findings from the Phase II CONTROL Trial with the Neratinib Arm of the Phase III ExteNET Trial at the ASCO 2021 Annual Meeting Dose escalation of neratinib lowers the frequency of severe diarrhea and improves overall tolerability in patients with HER2-positive early stage breast cancer pumabiotechnology.com ↗ |
| 2021-01-29 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung Cancer at WCLC 2020 pumabiotechnology.com ↗ |
| 2021-01-15 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results from the Biliary Tract Cancers Cohort of the Phase II SUMMIT “Basket” Trial of Neratinib at ASCO GI pumabiotechnology.com ↗
This resulted in an objective response rate of 16% and a clinical benefit rate of 28%. |
| 2020-12-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS Results show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer pumabiotechnology.com ↗
The NALA study met its primary endpoint, with the neratinib arm having significantly improved PFS vs. the lapatinib arm (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.93; stratified log-rank P = .0059; mean PFS 8.8 mo vs. 6.6 mo). |
| 2020-12-09 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Results from the Phase II SUMMIT Trial of Neratinib for HER2-Mutant, HR-Positive Metastatic Breast Cancer at SABCS 2020 pumabiotechnology.com ↗
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented updated results from the ongoing Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. |
| 2020-12-09 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Final Overall Survival Analysis from the Phase III ExteNET Trial at the 2020 SABCS Results show continued efficacy of neratinib in patients with HER2-positive early stage breast cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive early stage breast cancer (eBC) from the Phase III ExteNET trial were presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. |
| 2020-11-05 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18 Mutated, Metastatic Non-Small Cell Lung Cancer pumabiotechnology.com ↗
8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). |
| 2020-10-05 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of Overall Survival Results from Phase III ExteNET Trial Evaluating Neratinib in HER2-Positive, Hormone Receptor-Positive, Early Stage Breast Cancer Data published online in Clinical Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were published in Clinical Breast Cancer. |
| 2020-08-19 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of Interim Results of Phase II CONTROL Trial in Annals of Oncology - CONTROL Trial Investigates Anti-diarrheal Strategies Including Dose Escalation in Neratinib-treated Patients with Early Stage HER2-positive Breast Cancer - Dose Escalation Resulted in Reduced Rate, Severity and Duration of Grade ≥3 Diarrhea Compared to Phase III ExteNET Trial, Lower Diarrhea-related Discontinuations and Dose Reductions in Multiple CONTROL Cohorts pumabiotechnology.com ↗
The interim results of the CONTROL trial discussed in this publication demonstrate that neratinib tolerability can be significantly improved using a variety of anti-diarrheal strategies. |
| 2020-07-27 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of Results from Phase II SUMMIT Trial Evaluating Neratinib in HER2-Mutant, Metastatic Cervical Cancers Data published online in Gynecologic Oncology pumabiotechnology.com ↗
Three of 12 RECIST-measurable patients had confirmed partial responses (overall response rate of 25%; 95% CI 5.5–57.2%); three had stable disease more than 16 weeks (clinical benefit rate of 50%; 95% CI 21.1–78.9%). |
| 2020-07-16 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). |
| 2020-05-07 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Licensing Partner CANbridge Pharmaceuticals Receives Marketing Approval in Mainland China for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner CANbridge Pharmaceuticals, Inc. has received marketing approval of NERLYNX® (neratinib) in mainland China from the National Medical Products Administration (NMPA) of China. |
| 2020-02-26 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer pumabiotechnology.com ↗ |
| 2019-12-12 | Puma Biotechnology, Inc. | Results plasmaMATCH Trial Shows Neratinib Activity in ERBB2 (HER2) Mutant Metastatic Breast Cancer pumabiotechnology.com ↗ |
| 2019-12-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2019 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The median duration of response has not been reached and the median progression-free survival was 9.8 months. |
| 2019-12-02 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Singapore for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive HER2-Positive Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government. |
| 2019-11-05 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Licensing Partner CANbridge Pharmaceuticals Receives Registration Approval in Hong Kong for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive HER2-Positive Breast Cancer pumabiotechnology.com ↗ |
| 2019-10-02 | Puma Biotechnology, Inc. | Regulatory FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX® (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. |
| 2019-09-11 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer pumabiotechnology.com ↗
“The FDA’s acceptance of our sNDA marks another important regulatory milestone for my team,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. |
| 2019-09-04 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Licensing Partner Pint Pharma Receives Marketing Authorization for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive, HER2-Positive Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Agency of Medicines, Food and Medical Devices (ANMAT) in Argentina has granted approval of NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. |
| 2019-09-03 | Puma Biotechnology, Inc. | Regulatory FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases pumabiotechnology.com ↗
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases. |
| 2019-07-16 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology’s Licensing Partner Knight Therapeutics Receives Regulatory Approval from Health Canada to Commercialize NERLYNX® (neratinib) for Extended Adjuvant Treatment of Hormone Receptor Positive, HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Neratinib becomes the first anti-HER2 treatment to be approved in Canada, as extended adjuvant therapy for women with early stage HR-positive, HER2-positive breast cancer following adjuvant trastuzumab-based therapy. |
| 2019-07-03 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results from the Biliary Tract Cohort of its Phase II SUMMIT Basket Trial of Neratinib at the ESMO World Congress on Gastrointestinal Cancer 2019 pumabiotechnology.com ↗
The confirmed objective response rate was 10% (95% CI: 1.2–31.7). |
| 2019-07-01 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer pumabiotechnology.com ↗ |
| 2019-06-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL trial of Neratinib in Extended Adjuvant treatment of HER2-Positive Early Stage Breast Cancer at the ASCO 2019 Annual Meeting pumabiotechnology.com ↗
LOS ANGELES, Calif., June 2, 2019 - Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago. |
| 2019-03-18 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic Cervical Cancer at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting Oral Plenary Presentation Receives SGO Presidential Award pumabiotechnology.com ↗
The objective response rate was 27.3% (95% CI: 6.0%–61.0%). |
| 2019-03-18 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology’s Licensing Partner Specialised Therapeutics Asia Receives Regulatory Approval to Commercialize NERLYNX® (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Neratinib becomes the first anti-HER2 treatment to be approved in Australia, as extended adjuvant therapy for early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. |
| 2018-12-17 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Top Line Results of the Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer pumabiotechnology.com ↗
For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. |
| 2018-12-06 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2018 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
In this cohort, 43 patients (92%) had HER2-non-amplified disease, and patients had received a median of 3 prior lines of therapy in the metastatic setting (range 0-11 prior regimens) before entering the trial. |
| 2018-12-06 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, is presenting updated results from a Phase II clinical trial of Puma’s drug neratinib at the 2018 San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. |
| 2018-10-02 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology’s Licensing Partner CANbridge Pharmaceutical Submits New Drug Application for NERLYNX® (neratinib) in China pumabiotechnology.com ↗ |
| 2018-09-04 | Puma Biotechnology, Inc. | Regulatory European Commission Grants Marketing Authorisation for Puma Biotechnology’s NERLYNX® (neratinib) for Extended Adjuvant Treatment of Hormone Receptor Positive HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Neratinib becomes the first anti-HER2 treatment to be EC-approved as extended adjuvant therapy for early stage hormone receptor positive HER2-positive breast cancer following adjuvant trastuzumab-based therapy |
| 2018-07-31 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Files New Drug Submission for NERLYNX® in Canada pumabiotechnology.com ↗
Health Canada has accepted for review the Company’s New Drug Submission (NDS) for the medicinal product NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. |
| 2018-06-29 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX® for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗ |
| 2018-06-26 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces Results of CHMP Reexamination of MAA for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Today’s decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with the Company to discuss the MAA on February 23, 2018. |
| 2018-06-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2018 ASCO Annual Meeting pumabiotechnology.com ↗ |
| 2018-02-23 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application (MAA) for neratinib |
| 2018-01-31 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of Results from Phase II SUMMIT ‘Basket’ Trial Evaluating Neratinib in HER2 and HER3 Mutant Cancers pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that initial results from the company’s ongoing SUMMIT Phase II ‘basket’ clinical trial of PB272 (neratinib) in patients with tumors harboring HER2 or HER3 mutations were published in the journal Nature. |
| 2018-01-23 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces Results of CHMP Oral Explanation for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
CHMP indicated that, in its opinion, the benefit risk assessment is negative |
| 2017-12-13 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces Meeting of Scientific Advisory Group on Oncology in Europe to Review Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
the European Medicines Agency (EMA) has requested that the Scientific Advisory Group on Oncology provide an opinion on the clinical aspects of the Marketing Authorization Application (MAA) for neratinib |
| 2017-11-13 | Puma Biotechnology, Inc. | Results Puma Biotechnology’s 5-Year Analysis of Phase III ExteNET Study Published Online in The Lancet Oncology Data Demonstrates Continued Benefit from Neratinib after 5 years in Extended Adjuvant HER2-Positive Breast Cancer pumabiotechnology.com ↗
The predefined 5-year invasive disease free survival (iDFS) analysis as a follow-up to the primary 2-year iDFS analysis of the Phase III ExteNET trial was published online today. |
| 2017-09-08 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents 5-Year Analysis of Phase III ExteNET Trial in Extended Adjuvant HER2-Positive Breast Cancer at ESMO 2017 Congress pumabiotechnology.com ↗ |
| 2017-08-02 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Receives Day-180 List of Outstanding Issues from Committee for Medicinal Products for Human Use (CHMP) pumabiotechnology.com ↗
The CHMP has requested additional data analyses related to the safety and efficacy of neratinib and has instituted a clock stop in order to allow Puma time to respond to this List of Outstanding Issues. |
| 2017-07-17 | Puma Biotechnology, Inc. | Regulatory U.S. Food and Drug Administration Approves Puma’s NERLYNX™ (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Neratinib becomes the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. |
| 2017-06-03 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive PB272 Phase II Data from TBCRC 022 Trial in Patients with HER2-Positive Metastatic Breast Cancer with Brain Metastases at the 2017 ASCO Annual Meeting pumabiotechnology.com ↗
The efficacy results from the trial showed that 49% of patients experienced a CNS Objective Response by the composite criteria. |
| 2017-05-24 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib pumabiotechnology.com ↗ |
| 2017-04-17 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on May 24, 2017. |
| 2017-04-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
LOS ANGELES, Calif., April 4, 2017 - Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that interim results from a Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) were presented at the 2017 American Association for Cancer Research Annual Meeting (AACR) that is currently taking place in Washington, D.C. |
| 2017-04-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of PB272 for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
In the HER2-mutant cohort, clinical responses were observed in tumors with S310, L755, V777, P780_Y781insGSP and A775_G776insYVMA mutations. |
| 2017-04-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
For the 16 patients who were evaluable for efficacy, the objective response (CR/PR) rate was 56%. |
| 2016-12-08 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2016 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
LOS ANGELES, Calif., Dec. 8, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that interim results from a Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) were presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. |
| 2016-12-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2016 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The presentation at SABCS included an update on both the neratinib monotherapy cohort and the neratinib plus fulvestrant cohort. |
| 2016-09-20 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces U.S. FDA Acceptance of New Drug Application for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗ |
| 2016-08-22 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces European Medicines Agency Validation of Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that the Marketing Authorization Application (MAA) for neratinib has been validated by the European Medicines Agency (EMA). |
| 2016-07-21 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Interim 5-Year Disease Free Survival Data from Phase III Trial of PB272 (Neratinib) in Extended Adjuvant HER2-Positive Early Stage Breast Cancer (ExteNET Trial) pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced updated results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer (ExteNET trial). |
| 2016-07-21 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin®)-based therapy. |
| 2016-07-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces I-SPY 2 Phase II Study of Neratinib Published in The New England Journal of Medicine pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that the positive results from the I-SPY 2 Phase II clinical trial of neratinib for the neoadjuvant treatment of breast cancer were published in the July 7 issue of The New England Journal of Medicine . |
| 2016-06-27 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib. |
| 2016-06-05 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Positive Phase II Data at the 2016 ASCO Annual Meeting pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, presented positive results from an investigator sponsored Phase II trial of neratinib with HER2-mutated, non-amplified breast cancer. |
| 2016-04-20 | Puma Biotechnology, Inc. | Results Puma Biotechnology’s Neratinib Featured in Poster Presentations at the AACR Annual Meeting 2016 pumabiotechnology.com ↗
Data from three breast cancer patients in the ongoing phase II SUMMIT basket study of neratinib in ERBB2-mutant cancers who progressed following initial benefit from neratinib treatment identified a common genomic alteration in their tumors. |
| 2016-04-14 | Puma Biotechnology, Inc. | Results Puma Biotechnology’s NEfERT-T Phase II Study Published Online in JAMA Oncology pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that results from the NEfERT-T Phase II clinical trial of neratinib in ERBB2-positive metastatic breast cancer patients were published online in JAMA Oncology. |
| 2016-02-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology’s ExteNET Phase III Study Published Online in The Lancet Oncology pumabiotechnology.com ↗
The study demonstrated that the trial hit its primary endpoint and that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). |
| 2015-12-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents 3-Year Disease Free Survival Data from Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) at the 2015 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The results of the trial demonstrated that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). |
| 2015-12-10 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2015 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
For the 3 response-evaluable patients who have been enrolled and received the combination of neratinib plus fulvestrant, 3 (100%) of 3 patients have shown a response, including one patient with a complete response and two patients with partial responses. |
| 2015-09-26 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Presentation of Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) in Centrally Confirmed HER2-Positive Early Stage Breast Cancer Patients pumabiotechnology.com ↗
The data was presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) 2015 Breast Cancer Symposium in San Francisco, California. |
| 2015-09-10 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Publication of PB272 in HER2 Non-Amplified Metastatic Breast Cancer with a HER2 mutation pumabiotechnology.com ↗
The patient began treatment with neratinib and within two months her performance status improved, she was able to resume normal daily activities and a CT scan performed showed a partial response that persisted for 11 months. |
| 2015-06-01 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) Demonstrates Statistically Significant Improvement in Disease Free Survival pumabiotechnology.com ↗ |
| 2014-12-12 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive Interim PB272 (Neratinib) Phase II Data at 2014 CTRC-AACR San Antonio Breast Cancer Symposium Interim Phase II Results Demonstrate Efficacy of PB272 in Combination with Temsirolimus in HER2+ Metastatic Breast Cancer pumabiotechnology.com ↗ |
| 2014-11-13 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive Top Line Results from PB272 Phase II Trial in HER2 Positive Metastatic Breast Cancer (NEfERTT Trial) Neratinib Achieves Statistically Significant Reduction in Incidence of Central Nervous System Metastases pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced top line results from a Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the treatment of first-line HER2-positive locally recurrent or metastatic breast cancer (NEfERTT trial). |
| 2014-09-29 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive Initial Results from PB272 Phase II Trial in HER2 Mutated Non-Small Cell Lung Cancer pumabiotechnology.com ↗
The results of the study showed that the combination of PB272 and temsirolimus had acceptable tolerability. |
| 2014-07-22 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive Top Line Results from Phase III PB272 Trial in Adjuvant Breast Cancer (ExteNET Trial) Neratinib Achieves Statistically Significant Improvement in Disease Free Survival Company Plans to File for Regulatory Approval in First Half of 2015 pumabiotechnology.com ↗
The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. |
| 2014-06-01 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Presentation of Positive PB272 Phase II Data at the 2014 ASCO Annual Meeting pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced the presentation of positive results from an ongoing Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the treatment of HER2 positive metastatic breast cancer that has metastasized to the brain. |
| 2014-04-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Presentation of Positive PB272 Phase II Data from I-SPY 2 TRIAL Neratinib Graduates from I-SPY 2 TRIAL pumabiotechnology.com ↗
The presentation entitled “Neratinib plus Standard Neoadjuvant Therapy for High-Risk Breast Cancer: Efficacy Results from the I-SPY 2 TRIAL” was presented today at the session entitled “Clinical Trials Symposium: Biomarker Driven Clinical Trials.” |
| 2013-12-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Reports Positive Top Line Data from I-SPY 2 TRIAL Neratinib Graduates from I-SPY 2 TRIAL pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, today announced top line results from the Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the neoadjuvant treatment of breast cancer (I-SPY 2 TRIAL). |
| 2013-02-20 | Puma Biotechnology, Inc. | Regulatory Puma Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of PB272 (Neratinib) in HER2-Positive Metastatic Breast Cancer Patients pumabiotechnology.com ↗
today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) |
| 2012-12-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium Phase II Results Demonstrate Efficacy of PB272 in Combination with Temsirolimus in HER2+ Metastatic Breast Cancer pumabiotechnology.com ↗
The results of the study presented showed that the combination of PB272 and temsirolimus had acceptable tolerability. |
| 2012-06-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Positive PB272 Clinical Data at ASCO 2012 Annual Meeting Phase I Results Demonstrate Safety and Efficacy of PB272 in Combination with Paclitaxel and Trastuzumab in Women with Metastatic HER-2 Positive Breast Cancer pumabiotechnology.com ↗
The results of the study showed that of the 120 mg PB272 dose group, 1 of 3 patients developed a dose limiting toxicity (DLT) consisting of grade 3 diarrhea. |
| 2011-12-09 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium Phase II Results Demonstrate Efficacy of PB272 in Combination with Capecitabine and in Combination with Temsirolimus in HER2+ Metastatic Breast Cancer pumabiotechnology.com ↗
The results of the study showed that the combination of PB272 and capecitabine had acceptable tolerability. |
All press releases naming this drug 145 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 145 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 90 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Neratinib | “In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab,...” NCT07153952 ↗83“Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion).” NCT03919292 ↗ “Neratinib : Week 1: 120 mg, Week 2: 160 mg, Week 3 and onwards: 240 mg/QD/Oral/Once daily” NCT05512182 ↗ “Neratinib Maleate Tablets: 240 mg, taken orally once daily with a meal” NCT06015113 ↗ “Intervention: HKI-272 (Neratinib)340 mg orally, once daily.” NCT01494662 ↗ “Neratinib: 240mg po QD, every 3 weeks” NCT04760431 ↗ “Neratinib” NCT05615818 ↗ |
| Known as | CDP-820 | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | HKI-272 | “Neratinib (HKI-272), an orally administered small molecule, is an irreversible inhibitor of pan ErbB receptor tyrosine kinases” NCT01008150 ↗6“A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor” NCT01128842 ↗ “Neratinib (HKI-272)” NCT00781430 ↗ |
| Known as | neratinib maleate | “To assess dose limiting toxicities and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of neratinib maleate (neratinib) and trastuzumab...” NCT05372614 ↗ |
| Known as | Neratinib maleate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | Neratinib Maleate Tablets | “Neratinib Maleate Tablets: 240 mg, taken orally once daily with a meal” NCT06015113 ↗ |
| Known as | Nerlynx | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Known as | WAY-179272 | ChEMBL registry synonym — accepted as the source's own label CHEMBL180022 ↗ |
| Action | Inhibit | “pan-ErbB inhibitor that blocks signal transduction via inhibition of three epidermal growth factor receptors” PMID 22371427 ↗ Feb 2012 |
| Modality | Small molecule | “a potent, irreversible, small-molecule, orally administered, pan-ErbB inhibitor” PMID 22371427 ↗ Feb 2012 |
| Route | Oral | “Administered Orally” NCT00146172 ↗ |
| Target | ERBB2 | “ErbB1, ErbB2 (Her2) and ErbB4” PMID 22371427 ↗ Feb 2012 |
| Target | ERBB4 | “ErbB1, ErbB2 (Her2) and ErbB4” PMID 22371427 ↗ Feb 2012 |