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Alectinib - Roche

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Drug Profile

Alectinib - Roche

Alternative Names: AF-802; Alecensa; ALECENSARO; Alectinib hydrochloride; CH-5424802; RG-7853; RO-5424802; RO-5452802

Latest Information Update: 01 Dec 2025

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Non-small cell lung cancer; Anaplastic large cell lymphoma
  • 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
  • 17 Oct 2025 Final efficacy and adverse events data from a phase III ALEX trial in Non small cell lung cancer presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)
  • 17 Oct 2025 Updated efficacy data from a phase III trial in Non-small cell lung cancer presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)

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