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 […]
Swiss pharma giant Roche and US precision therapy company Blueprint Medicines have entered into a worldwide licensing and collaboration deal potentially worth up to $1.703 billion for the latter’s cancer drug candidate pralsetinib. Through the deal, Roche gains exclusive rights for the co-development and marketing of the investigational drug for RET-altered cancers across the world […]
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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 […]
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