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 […]
Unum Therapeutics, a US biopharma company, has acquired Kiq, a biotech company focused on the discovery and development of precision kinase inhibitors, in an all-stock deal. Focused on developing therapies for solid tumors, Unum Therapeutics, through the deal gains access to a clinical-stage compound called PLX9486, which is a selective KIT D816V inhibitor. PLX9486 will […]
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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 […]
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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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