Drugs / Alectinib
Alectinib
also known as
Alecensa · RO5424802 · AF-802 · AF-802 HYDROCHLORIDE · ALECTINIB (CH5424802) · alectinib hydrochloride · ALECTINIBCH-5424802CH5424802CT-CH542 · CH-5424802 HYDROCHLORIDE · +3 more
Small molecule targets ALK, RET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ALK+ histiocytosis 2 milestones | |||||
| Filed | Japan (PMDA) | Alecensa | ALK+ histiocytosis | 2019-06-03 | “announced today that it filed an application for ALK Inhibitor, Alecensa® capsule 150 mg (generic name: alectinib) to MHLW” chugai-pharm.co.jp ↗ |
| Filed | US (FDA) | — | ALK+ histiocytosis | 2015-09-08 | “FDA has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib” gene.com ↗ |
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | Japan (PMDA) | Alecensa | non-small cell lung carcinoma | 2023-12-15 | “today announced that it filed regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of an ALK inhibitor Alecensa” chugai-pharm.co.jp ↗ |
| Filed | US (FDA) | Alecensa | non-small cell lung carcinoma | 2017-08-02 | “announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA)” gene.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | ALECENSA | — | 2017-11-06 – 2026-06-11 | fda.gov ↗ |
| Approved | EU (EMA) | Alecensa | — | 2017-02-16 | europa.eu ↗ |
| Approved | US (FDA) | ALECENSA | — | 2015-12-11 | fda.gov ↗ |
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT07001384 | Aug 2025 → Aug 2031 expected | ALK-positive anaplastic large cell lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06354387 | Feb 2022 → Feb 2026 | hepatocellular carcinoma | China Medical University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02621047 | Dec 2015 → Dec 2016 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02013219 | Apr 2014 → Feb 2020 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02023125 | Dec 2013 → Mar 2014 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01984229 | Dec 2013 → Mar 2014 | — | Hoffmann-La Roche | Completed | Met primary |
| Phase 1 | NCT01981005 | Nov → Dec 2013 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01940510 | Oct 2013 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/210 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07560410 | May 2026 → Jan 2029 expected | bone cancer | China Medical University Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06624059 | Nov 2024 → Aug 2026 overdue | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05987644 | Mar 2024 → Feb 2028 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Joshua Palmer | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05713006 | May 2022 → Dec 2026 expected | — | National Cancer Institute of Mexico | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04774718 | Sep 2021 → Feb 2032 expected | — | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03202940 | Sep 2017 → Jan 2029 expected | non-small cell lung carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03131206 | Jun 2017 → Nov 2018 | malignant endocrine neoplasm, non-small cell lung carcinoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02521051 | Sep 2015 → Apr 2022 | non-small cell lung carcinoma | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01871805 | Sep 2013 → Oct 2014 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 1/2 | NCT01801111 | Jun 2013 → Oct 2014 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 226 trials · 2 met primary | ||||||
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05725200 | Sep 2022 → Dec 2038 expected | colorectal cancer | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central 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 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04644315 | May 2021 → May 2022 | anaplastic large cell lymphoma, brain neoplasm, bronchogenic carcinoma, cholangiocarcinoma +8 | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2 | NCT05015010 | May 2021 → Dec 2024 overdue | non-small cell lung carcinoma | Italian Oncology Group for Clinical Research | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04302025 | Nov 2020 → Nov 2026 expected | non-small cell lung carcinoma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | 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 | NCT03779191 | Apr 2020 → Aug 2022 | non-small cell lung carcinoma | National Cancer Institute of Mexico | Completed | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04116541 | Jan 2020 → Oct 2026 expected | cancer | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03445000 | Nov 2018 → Mar 2021 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT03155009 | Jul 2017 → Sep 2019 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02314481 | May 2017 → Nov 2025 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02091141 | Apr 2014 → May 2023 | biliary tract cancer, salivary gland cancer, urinary bladder cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05987956 | Mar → Nov 2026 expected | non-small cell lung carcinoma | Medicine Invention Design, Inc | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05770037 | Dec 2023 → Oct 2029 expected | anaplastic large cell lymphoma, lymphoproliferative syndrome, neuroblastoma, renal cell carcinoma | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 37 trials · 4 met primary | ||||||
| Phase 3 | NCT05170204 | Nov 2022 → Jun 2030 expected | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03456076 | Aug 2018 → Jun 2023 overdue | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT03194893 | Jul 2017 → Sep 2025 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02838420 | Aug 2016 → May 2018 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02604342 | Nov 2015 → Jan 2017 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02075840 | Aug 2014 → Feb 2017 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05525338 | Mar 2022 → Dec 2025 overdue | non-small cell lung carcinoma | University Medical Center Groningen | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06709274 | Nov 2024 → Jan 2029 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02271139 | — | non-small cell lung carcinoma | Genentech, Inc. | No longer available | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT03158389 Background | May 2018 → Feb 2023 | adult glioblastoma | University Hospital Heidelberg | Completed | Mixed |
| Phase 2 | NCT05081674 Comparator | Jan 2020 → Jun 2023 | lung neoplasm | Hospital Israelita Albert Einstein | Completed | No outcome recorded |
| Phase 3 | NCT06765109 Comparator | Jul 2025 → Dec 2029 expected | non-small cell lung carcinoma | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03596866 Comparator | Apr 2019 → Feb 2024 | — | Takeda | Completed | Missed primary |
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 63
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Chugai Pharmaceutical | Regulatory Alecensa Receives the World-First Tumor-Agnostic Approval for ALK Fusion Gene-Positive Solid Tumors Across Adult and Pediatric Patients chugai-pharm.co.jp ↗
This is the world’s first tumor-agnostic approval for an ALK inhibitor. |
| 2026-05-18 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors chugai-pharm.co.jp ↗
The efficacy and safety of Alecensa for advanced or recurrent ALK fusion gene-positive solid tumors were evaluated in an investigator initiated Japanese Phase II clinical study (TACKLE study), and an approval for a partial change to the marketing authorization was obtained on May 18, 2026. |
| 2025-10-21 | Chugai Pharmaceutical | Results Alecensa Extends Median Overall Survival to Over 80 Months in ALK-Positive Metastatic Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
In the final analysis of overall survival (OS), a secondary endpoint of the ALEX study, the median survival time for Alecensa was 81.1 months compared to 54.2 months for crizotinib (hazard ratio[HR]=0.78, 95% CI: 0.56-1.08). |
| 2025-06-26 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion / Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients chugai-pharm.co.jp ↗
today announced that it has filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for an additional indication |
| 2024-08-28 | Chugai Pharmaceutical | Regulatory Alecensa Approved in Japan for the Additional Indication of Adjuvant Treatment for People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗ |
| 2024-08-02 | Chugai Pharmaceutical | Regulatory Chugai’s Alecensa Approved in Taiwan as an Adjuvant Treatment for Early Stage ALK-Positive Non-Small Cell Lung Cancer (NSCLC) chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter, Chugai) announced that Chugai Pharma Taiwan Ltd. (hereafter, CPT), a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Alecensa ® (alectinib) as an adjuvant treatment following tumor resection (tumors ≥ 4 cm or node positive) for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), on August 1, 2024. |
| 2024-06-10 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer roche.com ↗ |
| 2024-06-10 | Chugai Pharmaceutical | Regulatory Alecensa Approved by the European Commission as the First Adjuvant Treatment for People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗ |
| 2024-04-30 | Chugai Pharmaceutical | Regulatory CHMP Recommends EU Approval of Alecensa as an Adjuvant Treatment for Resected ALK-Positive Early-Stage Lung Cancer chugai-pharm.co.jp ↗ |
| 2024-04-19 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer roche.com ↗
Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour. |
| 2024-04-19 | Chugai Pharmaceutical | Regulatory Alecensa Approved by FDA as the First Adjuvant Treatment for People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
Alecensa is now the only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor. |
| 2024-04-18 | Genentech, Inc. | Regulatory FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer gene.com ↗
Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor. |
| 2024-04-08 | Nuvectis Pharma, Inc. | Results Nuvectis Pharma's NXP900 Demonstrates Robust Activity in Non-Small Cell Lung Cancer Cell Lines nuvectis.com ↗
In addition, NXP900 demonstrated potent, single agent, antiproliferative activity in anaplastic lymphoma kinase (ALK)-resistant NSCLC cells and synergistic effects in combination with alectinib in alectinib sensitive cells. |
| 2023-12-15 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it filed regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of an ALK inhibitor Alecensa ® Capsules 150 mg (Hereafter Alecensa) for Postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer. |
| 2023-10-20 | Chugai Pharmaceutical | Results Chugai’s Alecensa Reduces the Risk of Disease Recurrence or Death by 76% in People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced results from the primary analysis of the Phase III ALINA study of anti-cancer agent/ALK inhibitor Alecensa ® (alectinib), demonstrating a statistically significant and clinically meaningful improvement in disease-free survival (DFS; primary endpoint). |
| 2023-10-18 | Hoffmann-La Roche | Results Roche’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer roche.com ↗
The study results showed that Alecensa® (alectinib) reduces the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). |
| 2023-10-18 | Chugai Pharmaceutical | Results Roche Announces Updates on Alecensa for Adjuvant Therapy in ALK-Positive Early-Stage Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
Roche’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer |
| 2023-10-17 | Genentech, Inc. | Results Genentech’s Alecensa Reduces the Risk of Disease Recurrence or Death by an Unprecedented 76% in People With ALK-Positive Early-Stage Non-Small Cell Lung Cancer gene.com ↗
Genentech’s Alecensa Reduces the Risk of Disease Recurrence or Death by an Unprecedented 76% in People With ALK-Positive Early-Stage Non-Small Cell Lung Cancer |
| 2023-09-01 | Hoffmann-La Roche | Results Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. |
| 2023-09-01 | Chugai Pharmaceutical | Results Chugai’s Alecensa Delivers Positive Phase III Results for People with ALK-Positive Early-Stage Lung Cancer chugai-pharm.co.jp ↗
Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). |
| 2023-08-31 | Genentech, Inc. | Results Genentech’s Alecensa Delivers Unprecedented Phase III Results for People With ALK-Positive Early-Stage Lung Cancer gene.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. |
| 2020-05-29 | Chugai Pharmaceutical | Results Updated Data of Overall Survival and Safety from the ALEX Study for Chugai's Alecensa Presented at the 2020 American Society of Clinical Oncology (ASCO) chugai-pharm.co.jp ↗
Alecensa shows a clinically meaningful benefit in overall survival compared with crizotinib (The 5-year survival rate was 62.5% in Alecensa arm and 45.5% in crizotinib arm) |
| 2020-02-21 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for Additional Indication of Alecensa for Recurrent or Refractory ALK Fusion Gene-Positive Anaplastic Large Cell Lymphoma chugai-pharm.co.jp ↗ |
| 2019-09-30 | Hoffmann-La Roche | Results Roche to present results of first prospective trial using blood-based next generation sequencing which successfully identifies people for treatment with Alecensa roche.com ↗
Efficacy of Alecensa® (alectinib) in people identified to have ALK-positive non-small cell lung cancer using liquid biopsy is consistent with efficacy in those identified by tissue analysis in the pivotal Phase III ALEX study |
| 2019-09-29 | Genentech, Inc. | Results Genentech to Present Results of First Prospective Trial Using Blood-Based Next Generation Sequencing Which Successfully Identifies People for Treatment With Alecensa (Alectinib) gene.com ↗
Efficacy of Alecensa in people identified to have ALK-positive non-small cell lung cancer using liquid biopsy is consistent with efficacy in those identified by tissue analysis in the pivotal Phase III ALEX study |
| 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 ↗
Final PFS and updated data from the pivotal Phase III ALEX study reinforces efficacy of Alecensa in first-line ALK-positive non-small cell lung cancer and shows progression free survival of nearly three years |
| 2019-06-03 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication of ALK Inhibitor ALECENSA for Recurrent or Refractory ALK Fusion Gene-Positive Anaplastic Large Cell Lymphoma (ALCL) chugai-pharm.co.jp ↗ |
| 2019-06-03 | Chugai Pharmaceutical | Results Final Progression-Free Survival Data and the Second Interim Analysis of Overall Survival from the J-ALEX Study for Alecensa Presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting chugai-pharm.co.jp ↗
Alecensa reduced the risk of disease progression or death by 63% compared to crizotinib |
| 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 ↗
Basel, 22 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will today announce results from the phase III ALESIA study, showing that Alecensa® (alectinib) met its primary endpoint of investigator-assessed (INV) progression-free survival (PFS). |
| 2018-08-20 | Hoffmann-La Roche | Regulatory China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer roche.com ↗
The approval follows priority review of Alecensa in China and has been granted just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals, respectively. |
| 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. |
| 2018-05-16 | Chugai Pharmaceutical | Regulatory Chugai’s ALK Inhibitor “Alecensa ® ” Approved for the Treatment of First Line Therapy on ALK-Positive Non-Small Cell Lung Cancer in Taiwan chugai-pharm.co.jp ↗
Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region. |
| 2017-12-21 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted a marketing authorisation for Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). |
| 2017-12-21 | Chugai Pharmaceutical | Regulatory EU Follows US and Approves Chugai’s ALK Inhibitor "Alecensa ® " as First Line Therapy for ALK-Positive Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
This additional approval is based on results from the phase III ALEX study (NCT02075840). |
| 2017-11-08 | Chugai Pharmaceutical | Regulatory Chugai's ALK Inhibitor "Alecensa ® " Approved for the Treatment of First Line Therapy on ALK-Positive Non-Small Cell Lung Cancer in the US chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Genentech Inc. , a member of the Roche Group, obtained approval from the U.S. Food and Drug Administration (FDA), for Alecensa ® in the treatment of "anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)". |
| 2017-11-07 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
| 2017-11-06 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Alecensa (Alectinib) as First-Line Treatment for People with Specific Type of Lung Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
| 2017-10-13 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). |
| 2017-09-06 | Hoffmann-La Roche | Results Roche presents data from global phase III study showing significant clinical benefit of Alecensa (alectinib) in later-line advanced ALK-positive lung cancer roche.com ↗
“The strikingly positive results from the ALUR study across multiple endpoints provide strong further evidence of the efficacy of Alecensa in this setting,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. |
| 2017-08-02 | Genentech, Inc. | Regulatory FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer gene.com ↗
FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer |
| 2017-06-06 | Chugai Pharmaceutical | Results Data of Chugai's Alecensa ® Presented at the American Society of Clinical Oncology on Global Phase III ALEX Study chugai-pharm.co.jp ↗
The study also showed that Alecensa was well tolerated. |
| 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 |
| 2017-05-10 | Genentech, Inc. | Results Genentech to Present New Data on Personalized Medicines and Cancer Immunotherapies at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting gene.com ↗
New pivotal results for Perjeta® (pertuzumab) and Alecensa® (alectinib) demonstrating improvement over standards of care |
| 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. |
| 2017-04-10 | Chugai Pharmaceutical | Results Chugai's Alecensa ® Met Its Primary Endpoint in the ALEX Study chugai-pharm.co.jp ↗
Following the Japanese phase III J-ALEX study, the ALEX study, the head to head trial with crizotinib, Alecensa demonstrated a significant prolongation of PFS compared to crizotinib. |
| 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 |
| 2017-04-03 | Hoffmann-La Roche | Results Phase III ALUR study supports the use of Roche’s Alecensa for people with advanced ALK-positive lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III ALUR study met its primary endpoint, demonstrating that Alecensa® (alectinib) significantly improved progression-free survival (PFS) in people with anaplastic lymphoma kinase (ALK)-positive advanced (metastatic) non-small cell lung cancer (NSCLC) who had progressed following treatment with one prior line of both platinum-based chemotherapy and crizotinib, compared with chemotherapy. |
| 2017-02-27 | Chugai Pharmaceutical | Regulatory Chugai’s ALK Inhibitor “Alecensa ® ” Approved in Taiwan chugai-pharm.co.jp ↗ |
| 2017-02-21 | Hoffmann-La Roche | Regulatory Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
| 2017-02-21 | Chugai Pharmaceutical | Regulatory Chugai’s ALK Inhibitor “Alecensa ® ” Approved in the EU chugai-pharm.co.jp ↗
F. Hoffmann-La Roche Ltd. obtained conditional marketing authorization from the European Commission (EC) |
| 2016-12-16 | Hoffmann-La Roche | Regulatory CHMP recommends EU conditional approval of Roche’s Alecensa (alectinib) for people with previously treated ALK-positive NSCLC roche.com ↗
Today’s positive CHMP opinion is great news for people living with ALK-positive NSCLC and brings us one step closer to providing a much needed new treatment option for people and physicians in Europe. |
| 2016-10-04 | Hoffmann-La Roche | Regulatory US FDA grants Breakthrough Therapy Designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation (BTD) from the United States Food and Drug Administration (FDA) for its ALK inhibitor, Alecensa (alectinib). |
| 2016-10-03 | Genentech, Inc. | Regulatory FDA Grants Breakthrough Therapy Designation for Genentech’s Alecensa® (Alectinib) for First-Line Treatment of People with ALK-Positive NSCLC gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). |
| 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). |
| 2016-05-19 | Chugai Pharmaceutical | Results Chugai to Present Japanese Phase III Results on Alecensa ® at ASCO chugai-pharm.co.jp ↗
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). |
| 2016-05-18 | Genentech, Inc. | Results Phase III Study of Genentech’s Alecensa® (alectinib) Showed Superior Efficacy Versus Crizotinib in Japanese People with a Specific Type of Lung Cancer gene.com ↗
Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. |
| 2016-05-02 | Genentech, Inc. | Results Genentech Highlights Personalized Medicines and Cancer Immunotherapies at 2016 American Society of Clinical Oncology (ASCO) Annual Meeting gene.com ↗
Superiority results from Phase III study comparing Alecensa® (alectinib) to crizotinib |
| 2015-12-11 | Genentech, Inc. | Regulatory FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer gene.com ↗ |
| 2015-09-08 | Genentech, Inc. | Regulatory FDA Grants Genentech's Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer gene.com ↗ |
| 2015-05-13 | Genentech, Inc. | Results Genentech’s Investigational Medicine Alectinib Shrank Tumors in Nearly Half of People with Specific Type of Lung Cancer gene.com ↗
In addition, alectinib was shown to shrink tumors in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1 percent and 68.8 percent, respectively). |
All press releases naming this drug 64 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alectinib | “Alectinib (ALECENSA®) is a type of drug called a ‘tyrosine kinase inhibitor’” PMID 41217067 ↗ Nov 202560“Alectinib used outside of indication, based on biomarker” NCT04817956 ↗ “ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib” NCT04356118 ↗ “Alectinib 600 mg twice a day for 4 weeks” NCT04644432 ↗ “Alectinib” NCT05014464 ↗ |
| Known as | AF-802 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | AF-802 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | Alecensa | “A Pilot Study of Alectinib (Alecensa) in Combination With Nivolumab (Opdivo) in the Treatment of Recurrent or Refractory Hepatocellular Carcinoma Patients Guided With Serum...” NCT06354387 ↗3“Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators.” NCT07560410 ↗ “ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer” NCT05987956 ↗ “Alectinib (ALECENSA®) is a type of drug called a ‘tyrosine kinase inhibitor’” PMID 41217067 ↗ Nov 2025 |
| Known as | ALECTINIB (CH5424802) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | alectinib hydrochloride | “ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily” NCT05987956 ↗ |
| Known as | ALECTINIBCH-5424802CH5424802CT-CH542 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | CH-5424802 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | CH5424802 | “Alectinib/CH5424802 is a known inhibitor of anaplastic lymphoma kinase (ALK) and is being evaluated in clinical trials for the treatment of ALK fusion-positive non-small cell...” PMID 25349307 ↗ Oct 2014 |
| Known as | RG-7853 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | RG-7853,CH5424802 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738797 ↗ |
| Known as | RO5424802 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01940510 ↗ |
| Action | Inhibit | “Alectinib is a selective and potent anaplastic lymphoma kinase (ALK) inhibitor” PMID 29748847 ↗ May 2018 |
| Modality | Small molecule | “Alectinib is an anaplastic lymphoma kinase tyrosine kinase inhibitor (TKI)” PMID 27544060 ↗ Aug 2016 |
| Route | Oral | “Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.” NCT01801111 ↗ |
| Target | ALK | “Alectinib is a selective and potent anaplastic lymphoma kinase (ALK) inhibitor” PMID 29748847 ↗ May 2018 |