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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: 30 May 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
  • Phase II Solid tumours
  • Phase I/II Brain cancer; Thyroid cancer

Most Recent Events

  • 13 May 2025 The Massachusetts General Hospital terminates a phase I/II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in USA due to slow accrual (NCT02521051)
  • 28 Apr 2025 Chugai Pharmaceutical completes the phase III ALEX trial for Non-Small Cell Lung Cancer (Metastatic disease, Recurrent, Late-stage disease, First line therapy) in USA, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, France, Guatemala, Greece, Egypt, Hong Kong, Israel, Italy, South Korea, Mexico, New Zealand, Poland, Portugal, Russia, Serbia, Spain, Singapore, Switzerland, Thailand, Taiwan, Turkey, Ukraine, United Kingdom (PO) (NCT02075840)
  • 02 Oct 2024 Roche plans a phase II HORIZON 2 trial for Non-small cell lung cancer (Late-stage disease, neoadjuvant therapy, combination therapy) in Chile (PO) (NCT06624059)

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