Drugs / Crizotinib
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed RET fusion positive cancer 2 milestones | |||||
| Filed | US (FDA) | XALKORI | RET fusion positive cancer | 2015-12-08 | “FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for XALKORI ® (crizotinib)” pfizer.com ↗ |
| Filed | EU (EMA) | XALKORI | RET fusion positive cancer | — | “the European Medicines Agency (EMA) is reviewing an application to extend the marketing authorization of XALKORI” pfizer.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (8) | US (FDA) | XALKORI | — | 2013-11-20 – 2023-09-07 | fda.gov ↗ |
| Filed | US (FDA) | XALKORI | ALK-positive systemic anaplastic large cell lymphoma | 2020-09-23 | “the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib)” pfizer.com ↗ |
| Approved | EU (EMA) | Xalkori | — | 2012-10-23 | europa.eu ↗ |
| Approved | US (FDA) | XALKORI | — | 2011-08-26 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02277457 | Sep 2015 → Jun 2021 | non-small cell lung carcinoma | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded |
| Phase 133 trials · 2 met primary | ||||||
| Phase 1 | NCT04693468 | Dec 2020 → Dec 2027 expected | high grade malignant neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03978143 | Jun → Oct 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03137134 | Jun → Sep 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02511184 | Oct 2015 → Dec 2017 | — | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02510001 | Nov 2014 → Dec 2018 | colorectal cancer | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT02270034 | Aug 2014 → Oct 2020 | brain glioblastoma | Grupo Español de Investigación en Neurooncología | Completed | No outcome recorded |
| Phase 1 | NCT02207504 | Aug 2014 → Feb 2018 | castration-resistant prostate carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02074878 | Jun 2014 → May 2017 | breast cancer | Mothaffar Rimawi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01999972 | Feb 2014 → Feb 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01998126 | Dec 2013 → May 2017 | non-small cell lung carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT02006277 | Dec 2013 → Mar 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01606878 | Apr 2013 → Dec 2018 | anaplastic large cell lymphoma, childhood malignant neoplasm, neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01744652 | Mar 2013 → Mar 2019 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01644773 | Nov 2012 → Mar 2018 | diffuse intrinsic pontine glioma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01576406 | Jul 2012 → Jun 2016 | cancer of unknown primary site | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01549574 | May 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01579994 | Apr 2012 → Dec 2020 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01548144 | Apr 2012 → Aug 2021 | cancer of unknown primary site | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT01531361 | Feb 2012 → Jan 2021 | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01441388 | Dec 2011 → Nov 2013 | glioblastoma, hepatocellular carcinoma, renal cell carcinoma | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01419041 | Nov 2011 → Aug 2012 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01441128 | Sep 2011 → Feb 2014 | adenocarcinoma, large cell carcinoma, non-small cell lung carcinoma, squamous cell carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01121588 | Mar 2011 → Sep 2023 | cancer | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01297595 | Mar → Apr 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01250730 | Dec 2010 → Jan 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01121575 | Aug 2010 → Feb 2014 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01168934 | Aug → Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01149785 | Jul → Sep 2010 | — | Pfizer | Completed | Met primary |
| Phase 1 | NCT01147055 | Jul → Oct 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01082380 | Mar → Apr 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00965731 | Jan 2010 → Dec 2011 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00939731 | Jul → Aug 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00585195 | Apr 2006 → Jul 2020 | anaplastic large cell lymphoma, non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT04292119 | May 2020 → Dec 2022 | non-small cell lung carcinoma, refractory malignant neoplasm | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03947385 | Jun 2019 → Jan 2027 expected | colorectal cancer, cutaneous melanoma, uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02584634 | Dec 2015 → Feb 2021 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02574078 | Nov 2015 → Apr 2020 | non-small cell lung carcinoma | Bristol-Myers Squibb | Completed | Mixed |
| Phase 1/2 | NCT01712217 | Oct 2012 → Dec 2016 | non-small cell lung carcinoma | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00939770 | Sep 2009 → Dec 2018 | anaplastic large cell lymphoma, neuroblastoma, refractory malignant neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 245 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05725200 | Sep 2022 → Dec 2038 expected | colorectal cancer | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05014464 | Nov 2021 → Jun 2026 overdue | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04423185 | Aug 2020 → Jul 2026 overdue | — | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT04322890 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04322578 | Mar 2020 → Mar 2025 | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04283669 | Feb 2020 → Feb 2025 | NF2-related schwannomatosis, acoustic neuroma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT04084717 | Dec 2019 → Dec 2024 | non-small cell lung carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT04193007 | Dec 2019 → Dec 2021 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 2 | NCT04030429 | Sep 2019 → Jun 2025 | endometrial cancer | National Cheng-Kung University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03574402 | Jul 2018 → Dec 2022 | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Unknown | Met primary |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03088930 | Dec 2017 → Jan 2021 | non-small cell lung carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03768375 | Nov 2016 → Dec 2020 | extrahepatic bile duct carcinoma, gallbladder cancer | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT02612194 | Sep 2016 → Sep 2019 | ureter neoplasm, urethra neoplasm, urinary bladder neoplasm | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT06357975 | Jul 2016 → Nov 2022 overdue | adult lymphoma, plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | Met primary |
| Phase 2 | NCT02761057 | Jul 2016 → Oct 2023 | papillary renal cell carcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT06360575 | Jul 2016 → Nov 2022 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02946359 | Jul 2016 → Oct 2017 | lung adenocarcinoma | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02836847 | Jul 2016 → Dec 2019 | cholangiocarcinoma, gallbladder cancer | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT02638428 | Dec 2015 → Dec 2021 | childhood acute myeloid leukemia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04439253 | Aug 2015 → Mar 2020 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04439266 | Aug 2015 → Mar 2020 overdue | plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02664935 | May 2015 → Nov 2023 | adenocarcinoma, non-small cell lung carcinoma, squamous cell carcinoma | University of Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT02419287 | Apr 2015 → Dec 2022 | ALK-positive anaplastic large cell lymphoma | University of Milano Bicocca | Completed | No outcome recorded |
| Phase 2 | NCT02223819 | Mar 2015 → Jul 2019 | uveal melanoma | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02499614 | Dec 2014 → Jun 2018 | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Unknown | No outcome recorded |
| Phase 2 | NCT02134912 | Aug 2014 → Sep 2016 | lung adenocarcinoma, lung large cell carcinoma | SWOG Cancer Research Network | Terminated | No outcome recorded |
| Phase 2 | NCT02435108 | May 2014 → Jan 2016 | — | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | Met primary |
| Phase 2 | NCT02183870 | May 2014 → Jul 2018 | adenocarcinoma, non-small cell lung carcinoma | University of Cologne | Completed | No outcome recorded |
| Phase 2 | NCT01500824 | May 2014 → May 2016 | non-small cell lung carcinoma | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT02101385 | Apr 2014 → Feb 2021 | breast cancer | Bryan Schneider, MD | Completed | Missed primary |
| Phase 2 | NCT01979536 | Nov 2013 → Mar 2021 | ALK-positive anaplastic large cell lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01822496 | Nov 2013 → Jun 2018 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT01945021 | Sep 2013 → Jul 2015 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02034981 | Aug 2013 → Jun 2019 | hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT01524926 | Sep 2012 → Dec 2017 | alveolar rhabdomyosarcoma, alveolar soft part sarcoma, anaplastic large cell lymphoma, clear cell sarcoma +2 | European Organisation for Research and Treatment of Cancer - EORTC | Completed | Mixed |
| Phase 2 | NCT00932451 | Jan 2010 → Mar 2015 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05987332 | Oct 2023 → Jan 2027 expected | uveal melanoma | IDEAYA Biosciences | Active not recruiting | Met primary |
| Phase 2/3 | NCT03874273 | Feb 2019 → Feb 2021 | inflammatory myofibroblastic tumor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 36 trials · 3 met primary | ||||||
| Phase 3 | NCT07804186 | Sep 2026 → Mar 2034 expected | uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 3 | NCT03194893 | Jul 2017 → Sep 2025 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02201992 | Mar 2015 → May 2036 expected | non-small cell lung carcinoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01639001 | Sep 2012 → Jun 2015 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT01154140 | Jan 2011 → Nov 2013 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT00932893 | Sep 2009 → Mar 2012 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05160922 | Dec 2021 → Mar 2028 expected | anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, non-small cell lung carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03672643 | Jan 2019 → Sep 2023 | — | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03707847 | Oct 2018 → Feb 2020 | ALK-positive anaplastic large cell lymphoma | Mingzhi Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT02487316 | Jul 2015 → Nov 2017 | ALK-positive anaplastic large cell lymphoma | Jun Zhu | Withdrawn | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05792644 | Jan 2018 → May 2022 | ALK+ histiocytosis | Harbin Medical University | Completed | No outcome recorded |
| — | NCT05063058 | Jan 2016 → Nov 2019 | melanoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| — | NCT02194738 | Sep 2014 → Dec 2025 overdue | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT03085186 | — | inflammatory myofibroblastic tumor | Jean M. Tersak, M.D. | No longer available | No outcome recorded |
| — | NCT02824094 | — | non-small cell lung carcinoma | Pfizer | No longer available | No outcome recorded |
| — | NCT02473497 | — | neoplasm | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 1 | NCT01125904 Background | Jun 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT01970865 Background | Jan 2014 → Mar 2017 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03620643 Comparator | May 2019 → Aug 2024 | breast lobular carcinoma, gastric cancer, triple-negative breast carcinoma | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT07816380 Comparator | Oct 2026 → Dec 2028 expected | non-small cell lung carcinoma | Guangzhou JOYO Pharma Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06564324 Comparator | Nov 2024 → Jan 2029 expected | non-small cell lung carcinoma | Nuvation Bio Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06254599 Comparator | May 2024 → May 2026 overdue | non-small cell lung carcinoma | Shouyao Holdings (Beijing) Co. LTD | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06140836 Comparator | Dec 2023 → Feb 2027 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06082635 Comparator | Dec 2023 → Apr 2026 overdue | non-small cell lung carcinoma | Shenzhen TargetRx Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05204628 Comparator | Feb 2022 → May 2025 | non-small cell lung carcinoma | Xuanzhu Biopharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04603807 Comparator | Sep 2021 → Jun 2028 expected | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04009317 Comparator | Aug 2019 → Oct 2021 | non-small cell lung carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT04632758 Comparator | Jun 2019 → Dec 2024 | non-small cell lung carcinoma | Qilu Pharmaceutical Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03052608 Comparator | Apr 2017 → Mar 2020 overdue | non-small cell lung carcinoma | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT02838420 Comparator | Aug 2016 → May 2018 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02767804 Comparator | Jun 2016 → Dec 2025 overdue | non-small cell lung carcinoma | Xcovery Holdings, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT02737501 Comparator | May 2016 → Jul 2020 | non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02075840 Comparator | Aug 2014 → Feb 2017 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| — | NCT02701231 Background | Nov 2015 → Dec 2020 | lung cancer | Chinese PLA General Hospital | Unknown | No outcome recorded |
| — | NCT00828919 Background | Mar 2003 → Aug 2023 | cancer | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | IDEAYA Biosciences | Results IDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at ASCO ideayabio.com ↗
Darovasertib combination resulted in a statistically significant and clinically meaningful improvement in median PFS vs. investigator's choice of therapy (ICT) – 6.9 months vs. 3.1 months, HR: 0.42, 58% reduction in risk of disease progression |
| 2026-05-29 | Pfizer | Results Seven-Year Analysis from Pfizer’s LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced Non-Small Cell Lung Cancer pfizer.com ↗
At seven years, patients treated with LORBRENA had a 55% likelihood of remaining alive without disease progression (95% Confidence Interval [CI], 46-63) compared to 3% (95% CI, 1-8) in the XALKORI treatment arm. |
| 2026-04-30 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program ideayabio.com ↗ |
| 2026-04-13 | IDEAYA Biosciences | Results IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma ideayabio.com ↗
The darovasertib combination met the trial's primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). |
| 2025-10-20 | IDEAYA Biosciences | Results IDEAYA Biosciences Reports Positive Median Overall Survival Data from Phase 2 Trial of the Darovasertib and Crizotinib Combination in First-line Metastatic Uveal Melanoma at the 2025 Society for Melanoma Research Congress ideayabio.com ↗
Across all 44 patients treated with the darovasertib and crizotinib combination, a median OS of 21.1 months and a median PFS of 7.0 months was observed. |
| 2024-05-31 | Pfizer | Results Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression pfizer.com ↗
Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm. |
| 2023-10-23 | IDEAYA Biosciences | Results IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline ideayabio.com ↗
60% confirmed ORR% by RECIST 1.1 in HLA-A2(+) in 1L MUM, and 42% confirmed ORR% by RECIST 1.1 in HLA-A2(-) in 1L MUM |
| 2023-10-17 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2023 for Phase 2 Clinical Data Update for Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma ideayabio.com ↗
Darovasertib and Crizotinib combination observed manageable safety profile and clinical efficacy that appears superior to current standard of care in MUM |
| 2023-05-09 | IDEAYA Biosciences | Results IDEAYA Biosciences, Inc. Reports First Quarter 2023 Financial Results and Provides Business Update ideayabio.com ↗
IDEAYA reported data from its ongoing Phase 2 clinical trial, designated as IDE196-001, demonstrating compelling clinical efficacy of the darovasertib and crizotinib combination therapy in first-line and any-line MUM patients. |
| 2023-04-23 | IDEAYA Biosciences | Results IDEAYA Announces Positive Interim Phase 2 Data for Darovasertib and Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in First-Line Metastatic Uveal Melanoma ideayabio.com ↗
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385). |
| 2022-12-05 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizotinib for the Treatment of Metastatic Uveal Melanoma ideayabio.com ↗
Fast Track designation granted by U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM) |
| 2022-09-11 | IDEAYA Biosciences | Results IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma ideayabio.com ↗
Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patients |
| 2021-12-07 | IDEAYA Biosciences | Results IDEAYA Reports Clinical Data from Phase 2 Expansion Dose of Darovasertib and Crizotinib Synthetic Lethal Combination in Heavily Pre-Treated Metastatic Uveal Melanoma ideayabio.com ↗
These data provide clinical proof-of-concept for the PKC and cMET synthetic lethal combination, and further validate IDEAYA's synthetic lethality platform. |
| 2021-09-02 | Xcovery Holdings, Inc. | Results Ensartinib published phase 3 global trial results in the journal of JAMA Oncology Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase−Positive Non–Small Cell Lung Cancer A Randomized Clinical Trial xcovery.com ↗ |
| 2021-05-10 | IDEAYA Biosciences | Results IDEAYA Announces Dose Expansion in Phase 1/2 Study of Darovasertib and Crizotinib Combination based on Early Clinical Efficacy in First Combination Cohort ideayabio.com ↗
We are encouraged to see the early deep partial response in the first cohort of the darovasertib and crizotinib combination. |
| 2021-02-13 | Exelixis | Results Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU exelixis.com ↗
Enrollment into additional arms of the study examining the use of crizotinib or savolitinib was halted early based on predefined interim futility analyses comparing these agents with the sunitinib arm. |
| 2021-01-14 | Pfizer | Regulatory Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults pfizer.com ↗ |
| 2020-11-19 | Pfizer | Results Results from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) in Previously Untreated ALK-Positive Lung Cancer Published in the New England Journal of Medicine pfizer.com ↗
At a planned interim analysis, LORBRENA treatment resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) according to blinded independent central review (BICR), the primary endpoint, compared to XALKORI |
| 2020-09-23 | Pfizer | Regulatory FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI® (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma pfizer.com ↗ |
| 2020-05-29 | Hoffmann-La Roche | Results Updated data demonstrate Roche’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer roche.com ↗
The updated results from the ALEX study show a five-year survival rate of 62.5% (95% CI: 54.3-70.8) in the Alecensa treatment group, versus 45.5% (95% CI: 33.6-57.4) with crizotinib. |
| 2019-09-28 | Hoffmann-La Roche | Results Roche to present new and updated data at ESMO 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer roche.com ↗
These data further support the benefits of Alecensa in the real-world setting, where real-world progression free survival (rwPFS), time to treatment discontinuation (TTD - used as a surrogate for real-world treatment duration) and overall survival (OS) were demonstrated to be longest in Alecensa treated patients with previously untreated ALK-positive NSCLC. |
| 2018-10-22 | Hoffmann-La Roche | Results Roche's Alecensa (alectinib) significantly reduced the risk of disease worsening or death as first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer roche.com ↗
Median PFS reported by the investigators was not yet reached in patients who received Alecensa (95% CI: 20.3 months-not reached) versus 11.1 months (95% CI: 9.1-13.0 months) in those who received crizotinib. |
| 2018-05-29 | Pfizer | Regulatory Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications pfizer.com ↗
The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. |
| 2018-05-17 | Hoffmann-La Roche | Results Follow-up phase III data showed Roche’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death roche.com ↗
The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95% CI: 17.7 months-NE) versus 10.9 months [95% CI: 9.1-12.9 months)], respectively, as assessed by the investigator. |
| 2018-05-16 | Genentech, Inc. | Results Follow-Up Phase III Data Showed Genentech’s Alecensa Helped People With Alk-Positive Metastatic Non-Small Cell Lung Cancer Live A Median Of Almost Three Years Without Their Disease Worsening Or Death gene.com ↗
The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95 percent CI: 17.7 months-NE] versus 10.9 months [95 percent CI: 9.1-12.9]), respectively, as assessed by the investigator. |
| 2017-09-11 | Pfizer | Results Pfizer Presents Overall Survival Data of XALKORI in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced final overall survival (OS) data from the PROFILE 1014 trial examining XALKORI® (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer(NSCLC). |
| 2017-06-05 | Hoffmann-La Roche | Results Phase III study showed Roche’s Alecensa (alectinib) reduced the risk of disease progression or death by more than half versus crizotinib as first-line treatment in a specific type of lung cancer roche.com ↗ |
| 2017-06-05 | Genentech, Inc. | Results Phase III Study Showed Genentech’s Alecensa (Alectinib) Reduced the Risk of Disease Progression or Death by More Than Half Versus Crizotinib as First-Line Treatment in a Specific Type of Lung Cancer gene.com ↗
Phase III Study Showed Genentech’s Alecensa (Alectinib) Reduced the Risk of Disease Progression or Death by More Than Half Versus Crizotinib as First-Line Treatment in a Specific Type of Lung Cancer |
| 2017-04-10 | Hoffmann-La Roche | Results Phase III study shows Roche’s Alecensa was superior to crizotinib in a specific type of lung cancer roche.com ↗
This is the second phase III trial to show that Alecensa was superior as an initial treatment compared to crizotinib in this type of lung cancer. |
| 2017-04-09 | Genentech, Inc. | Results Phase III Study Shows Genentech’s Alecensa® Was Superior to Crizotinib in a Specific Type of Lung Cancer gene.com ↗
Results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment |
| 2016-08-31 | Pfizer | Regulatory XALKORI® (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved XALKORI ® (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). |
| 2016-05-19 | Hoffmann-La Roche | Results Phase III study of Roche’s Alecensa (alectinib) showed superior efficacy versus crizotinib in Japanese people with a specific type of lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Alecensa® , an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). |
| 2016-03-11 | Pfizer | Regulatory XALKORI® (crizotinib) Approved by U.S. FDA for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI ® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. |
| 2015-12-08 | Pfizer | Regulatory Pfizer Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for XALKORI® (crizotinib) for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for XALKORI ® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. |
| 2015-11-24 | Pfizer | Regulatory Pfizer Receives European Approval to Expand Use of XALKORI® (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved a label update to expand use of XALKORI® (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
| 2015-11-18 | Pfizer | Results Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI® (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) pfizer.com ↗
When evaluated specifically in East Asian patients with ALK-positive NSCLC, XALKORI was demonstrated to be superior to chemotherapy in terms of prolonging progression-free survival. |
| 2015-04-21 | Pfizer | Regulatory Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. announced today that XALKORI® (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). |
All press releases naming this drug 51 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 124 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | crizotinib | “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗113“Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor that targets ALK and MET, and potentially other RTKs.” PMID 22316363 ↗ Feb 2012 “Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor that targets ALK and MET, and potentially other RTKs.” PMID 22316363 ↗ Feb 2012 “if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）” NCT04193007 ↗ “Single 250 mg crizotinib dose as coated microsphere 1 (cMS1) formulation will be administered” NCT03978143 ↗ “With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib.” NCT02701231 ↗ “MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d)” NCT05063058 ↗ “Arm B: Crizotinib monotherapy at 250 mg twice daily (BID)” NCT06564324 ↗ “Crizotinib is a medication that is taken by mouth.” NCT02074878 ↗ “ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib” NCT04356118 ↗ “Crizotinib 250 mg twice a day for 4 weeks” NCT04644432 ↗ |
| Known as | NSC-756645 | ChEMBL registry synonym — accepted as the source's own label CHEMBL601719 ↗ |
| Known as | PF-02341066 | “A Phase 1, Fixed Sequence, Cross-Over Study To Estimate The Effect Of Multiple Dose Rifampin On The Single Dose Pharmacokinetics Of Crizotinib (PF-02341066) In Healthy Volunteers” NCT01147055 ↗13“A Phase 1, Single Dose, Randomized, Cross-Over Absolute Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of Crizotinib (PF-02341066)” NCT01168934 ↗ “Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)” NCT01121588 ↗ “Crizotinib (PF-02341066)” NCT01524926 ↗ |
| Known as | Pf-2341066 | ChEMBL registry synonym — accepted as the source's own label CHEMBL601719 ↗ |
| Known as | XALKORI | “Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or...” NCT02824094 ↗3“Crizotinib, also called XALKORI, is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer.” NCT04084717 ↗ “The marketing name of the drug is "Xalkori".” NCT02074878 ↗ “Drug: Crizotinib (Xalkori)” NCT07804186 ↗ |
| Action | Inhibit | “Macrophage-stimulating protein receptor inhibitor” CHEMBL601719 ↗1“targets ALK and MET” PMID 22316363 ↗ Feb 2012 |
| Modality | Small molecule | “Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor” PMID 22316363 ↗ Feb 2012 |
| Route | Oral | “PF-02341066 is taken by mouth daily.” NCT00585195 ↗ |
| Target | ALK | “targets ALK and MET” PMID 22316363 ↗ Feb 2012 |
| Target | MET | “targets ALK and MET” PMID 22316363 ↗ Feb 2012 |
| Target | MST1R | “Macrophage-stimulating protein receptor inhibitor” CHEMBL601719 ↗ |