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 […]
Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib. The decision from the FDA marks Qinlock as the first drug approved in […]
Continue reading …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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