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Silevertinib - Black Diamond Therapeutics

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Drug Profile

Silevertinib - Black Diamond Therapeutics

Alternative Names: BDTX-1535

Latest Information Update: 13 Aug 2026

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At a glance

  • Originator Black Diamond Therapeutics
  • Class 2 ring heterocyclic compounds; Amides; Amines; Aniline compounds; Antineoplastics; Halogenated hydrocarbons; Morpholines; Quinazolines; Small molecules
  • Mechanism of Action ErbB receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Glioblastoma; Non-small cell lung cancer

Highest Development Phases

  • Phase II Glioblastoma
  • Phase I/II Non-small cell lung cancer
  • Phase 0 Glioma

Most Recent Events

  • 06 Aug 2026 Black Diamond Therapeutics anticipates regulatory feedback from the US FDA on registration path of silevertinib for Non-small cell lung cancer (First-line therapy) in the fourth quarter of 2026 (Black Diamond pipeline, May 2026)
  • 02 Jun 2026 Efficcay and adverse event data from phase I/II trial in Non-small cell lung cancer presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)
  • 21 May 2026 Efficacy and adverse events data from a phase I/II trial in Non small cell lung cancer released by Black Diamond Therapeutics

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