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Blueprint Medicines' Ayvakit (avapritinib) Receives FDA's Approval to Treat Patients with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

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Blueprint Medicines' Ayvakit (avapritinib) Receives FDA's Approval to Treat Patients with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

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  • The US FDA approval is based on P-I NAVIGATOR trial assessing avapritinib (300mg or 400mg- qd) in 43 patients with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations- including 38 patients with PDGFRA D842V mutations
  • The study resulted in patients with PDGFRA exon 18 mutant GIST: ORR 84%- CR 7%- PR 77%. And in patients with PDGFRA D842V mutations: ORR 89%- CR 8%- PR 82%- mDOR was not reached
  • Ayvakit (avapritinib) is a KIT and PDGFRA mutant kinases inhibitor and is novel candidate approved for type 1 inhibitor for GIST and has also received the US FDA’s BT Designation. The PDUFA date for fourth-line GIST indication is currently Feb 14- 2020

Click here to read full press release/ article | Ref: Blueprint Medicines | Image: Twitter


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