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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


Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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