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    Association details:
    Biomarker:PDGFRA exon 18 mutation
    Cancer:Gastrointestinal Stromal Tumor
    Drug:Ayvakit (avapritinib) (CSF-1R inhibitor, PDGFR antagonist, mutant c-KIT inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    CStone Pharma Press Release
    Title:

    CStone Announces China NMPA New Drug Approval of Precision Therapy AYVAKIT® (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

    Published date:
    03/31/2021
    Excerpt:
    ...CStone Pharmaceuticals...a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration (NMPA) of China has approved AYVAKIT (avapritinib) tablets for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation...
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Gastrointestinal Stromal Tumors: First-line therapy…Preferred Regimens…Avapritinib (for GIST with PDGFRA exon 18 mutations, including the PDGFRA D842V mutation)...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST

    Excerpt:
    ...Patient has received 3 or more TKI therapies including imatinib, or the patient has GIST that carries a mutation in exon 18 of the PDGFRA gene (such as D842V)....
    Trial ID:
    NCT03862885