Alectinib - Roche
Alternative Names: AF-802; Alecensa; ALECENSARO; Alectinib hydrochloride; CH-5424802; RG-7853; RO-5424802; RO-5452802Latest Information Update: 01 Dec 2025
At a glance
- Originator Chugai Pharmaceutical
- Developer Chugai Pharmaceutical; Roche
- Class Antineoplastics; Carbazoles; Morpholines; Nitriles; Phenyl ethers; Piperidines; Small molecules
- Mechanism of Action Anaplastic lymphoma kinase inhibitors
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Orphan Drug Status
Yes - Non-small cell lung cancer; Anaplastic large cell lymphoma
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Anaplastic large cell lymphoma; Non-small cell lung cancer
- Preregistration Solid tumours
- Phase I/II Brain cancer; Thyroid cancer
Most Recent Events
- 21 Oct 2025 Efficacy data from a phase III ALEX trial in Non-Small Cell Lung Cancer released by Chugai Pharmaceutical
- 30 Jun 2025 Preregistration for ALK fusion/rearrangement positive Solid tumours (Inoperable/Unresectable, Late-stage disease, Recurrent) in Japan (PO) (Chugai Pharmaceutical pipeline, November 2025)
- 30 May 2025 Efficacy and adverse events data from a phase I/II trial in solid tumor presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)