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FDA Approves Blueprint Medicines' Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis drugs
June 21, 2021
Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that the U.S. Food and Drug Administration (FDA) has approved Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM)
FDA Approves Avapritinib for Advanced Systemic Mastocytosis americanpharmaceuticalreview
June 18, 2021
The U.S. FDA approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated ...
CStone Announces Acceptance of New Drug Application in Hong Kong, S.A.R., China for Avapritinib for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumor prnasia
May 12, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced the acceptance of the company's new drug application ...
CStone Announces Preliminary Results from a Bridging Study of Avapritinib in Chinese Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors at the 2020 CSCO Annual Meeting prnasia
September 27, 2020
CStone Pharmaceuticals (SUZHOU) Co., Ltd. presented positive results at the 2020 Chinese Society of Clinical Oncology (CSCO) Annual Meeting from a phase I/II bridging study in China evaluating avapritinib in patients with unresectable or metastatic ...
Blueprint Medicines Receives CRL for Avapritinib americanpharmaceuticalreview
May 20, 2020
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of avapritinib.
Blueprint Medicines Announces EMA Validation for Avapritinib americanpharmaceuticalreview
July 22, 2019
Blueprint Medicines announced the European Medicines Agency (EMA) has validated the company's Marketing Authorization Application (MAA) for avapritinib for the treatment of adult patients with PDGFRα D842V mutant gastrointestinal stromal tumors (GIST) ...
CStone announces first patient dosed in China with avapritinib for advanced GIST biospectrumasia
July 10, 2019
Global Phase III clinical trial to evaluate the safety and efficacy of avapritinib as a 3rd or 4th line treatment for patients with gastrointestinal stromal tumours (GIST), in comparison with regorafenib
Blueprint Medicines Submits NDA for Avapritinib americanpharmaceuticalreview
June 20, 2019
Blueprint Medicines has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST) ...
Blueprint eyes quick filing for GIST drug avapritinib pharmaphorum
December 13, 2018
Blueprint Medicines has new data for its lead cancer drug avapritinib in gastrointestinal stromal tumours (GIST) that set it on course for regulatory filings – and a close race to market with rival Deciphera.
Blueprint Announces Updated Results from Ongoing Avapritinib Trial americanpharmaceuticalreview
December 04, 2018
Blueprint Medicines announced updated results for the Phase 1 EXPLORER clinical trial of avapritinib, a potent and highly selective inhibitor of D816V mutant KIT.....