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Alpelisib companion diagnostic - Foundation Medicine

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Drug Profile

Alpelisib companion diagnostic - Foundation Medicine

Alternative Names: Alpelisib - FoundationOne® CDx Cancer Genomic Profile; BYL719 companion diagnostic - Foundation Medicine; NVP BYL 719 companion diagnostic - Foundation Medicine; Piqray companion diagnostic - Foundation Medicine

Latest Information Update: 17 Sep 2024

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At a glance

  • Originator Foundation Medicine
  • Class Diagnostic agents
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Breast cancer

Most Recent Events

  • 17 Sep 2024 Launched for Breast cancer (Diagnosis) in USA (unspecified route), prior to September 2024 (Foundation Medicine website, September 2024)
  • 27 Oct 2020 US FDA approves alpelisib companion diagnostic for the diagnosis of advanced or metastatic breast cancer
  • 04 Dec 2019 Registered for Breast cancer (Diagnosis) in USA (unspecified route)

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