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Entrectinib - Roche

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Drug Profile

Entrectinib - Roche

Alternative Names: Entrectinib - Ignyta; NMS-E628; RG 6268; Rozlytrek; RXDX-101; TrkA/TrkB/TrkC/ROS1/ALK inhibitor - Roche

Latest Information Update: 16 Oct 2025

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At a glance

  • Originator Nerviano Medical Sciences
  • Developer Alliance for Clinical Trials in Oncology; Chugai Biopharmaceuticals; Genentech; National Cancer Institute (USA); Roche; University of California at San Francisco
  • Class Antineoplastics; Benzamides; Fluorinated hydrocarbons; Indazoles; Piperazines; Pyrans; Small molecules; Tumour-agnostic therapies
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; ROS1 protein inhibitors; TrkA receptor antagonists; TrkB receptor antagonists; TrkC receptor antagonists
  • Orphan Drug Status

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

    Yes - Neuroblastoma; Non-small cell lung cancer; Solid tumours; Colorectal cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Solid tumours
  • Phase II Brain metastases; Malignant melanoma
  • Phase I/II Uveal melanoma
  • No development reported Acute myeloid leukaemia

Most Recent Events

  • 08 Oct 2025 Alliance for Clinical Trials in Oncology suspends the Phase-II clinical trials in Brain metastases in USA (PO) due to interim analysis (NCT03994796)
  • 28 May 2025 Integrated efficacy and safety data from the phase I/II STARTRK-NG, phase II TAPISTRY and pivotal phase II STARTRK-2 trials in Solid tumours presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 27 Feb 2024 Genentech completes a phase II trial in Solid tumours (Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (PO) (NCT04632992)

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