CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

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CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for avapritinib as a monotherapy for certain types of gastrointestinal stromal tumors (GIST). CHMP has recommended conditional marketing authorization of the kinase inhibitor in the European Union for […]

FDA rejects Blueprint’s NDA for AYVAKIT for treatment of fourth-line GIST

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FDA rejects Blueprint’s NDA for AYVAKIT for treatment of fourth-line GIST

Blueprint Medicines said that the US Food and Drug Administration (FDA) has rejected its new drug application (NDA) for AYVAKIT (avapritinib) for the treatment of fourth-line gastrointestinal stromal tumor (GIST). The US precision therapy company received a complete response letter (CRL) from the FDA in this connection. Blueprint Medicines was seeking FDA approval for avapritinib […]