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 · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |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 | ||||||
| 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 | NCT01984229 | Dec 2013 → Mar 2014 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02023125 | Dec 2013 → Mar 2014 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| 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 | ||||||
| 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 |
| Phase 1/2 | NCT02521051 | Sep 2015 → Apr 2022 | non-small cell lung carcinoma | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1/2 | NCT01871805 | Sep 2013 → Oct 2014 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT01801111 | Jun 2013 → Oct 2014 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 226 trials | ||||||
| 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 | No outcome recorded |
| 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 |
| 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 |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02604342 | Nov 2015 → Jan 2017 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02075840 | Aug 2014 → Feb 2017 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03158389 Background | May 2018 → Feb 2023 | adult glioblastoma | University Hospital Heidelberg | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05081674 Comparator | Jan 2020 → Jun 2023 | lung neoplasm | Hospital Israelita Albert Einstein | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| 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 | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
Press releases naming this drug 21 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-06-10 | Roche Global Development | 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 ↗ |
| 2024-04-19 | Roche Global Development | FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer roche.com ↗ |
| 2023-10-18 | Roche Global Development | 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 ↗ |
| 2023-09-01 | Roche Global Development | Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer roche.com ↗ |
| 2020-05-29 | Roche Global Development | Updated data demonstrate Roche’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer roche.com ↗ |
| 2019-09-30 | Roche Global Development | Roche to present results of first prospective trial using blood-based next generation sequencing which successfully identifies people for treatment with Alecensa roche.com ↗ |
| 2019-09-28 | Roche Global Development | 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 ↗ |
| 2018-10-22 | Roche Global Development | 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 ↗ |
| 2018-08-20 | Roche Global Development | China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer roche.com ↗ |
| 2018-05-17 | Roche Global Development | 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 ↗ |
| 2017-12-21 | Roche Global Development | European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer roche.com ↗ |
| 2017-11-07 | Roche Global Development | FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer roche.com ↗ |
| 2017-10-13 | Roche Global Development | CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC roche.com ↗ |
| 2017-09-06 | Roche Global Development | 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 ↗ |
| 2017-06-05 | Roche Global Development | 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 ↗ |
| 2017-04-10 | Roche Global Development | Phase III study shows Roche’s Alecensa was superior to crizotinib in a specific type of lung cancer roche.com ↗ |
| 2017-04-03 | Roche Global Development | Phase III ALUR study supports the use of Roche’s Alecensa for people with advanced ALK-positive lung cancer roche.com ↗ |
| 2017-02-21 | Roche Global Development | Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer roche.com ↗ |
| 2016-12-16 | Roche Global Development | CHMP recommends EU conditional approval of Roche’s Alecensa (alectinib) for people with previously treated ALK-positive NSCLC roche.com ↗ |
| 2016-10-04 | Roche Global Development | US FDA grants Breakthrough Therapy Designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC roche.com ↗ |
| 2016-05-19 | Roche Global Development | 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 ↗ |
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 ↗ “Alectinib (ALECENSA®) is a type of drug called a ‘tyrosine kinase inhibitor’” PMID 41217067 ↗ Nov 2025 “ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily” NCT05987956 ↗ |
| 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 |