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NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended conditional marketing authorization for avapritinib (Blueprint Medicines' Ayvakyt) for adults with unresectable or metastatic gastrointestinal stromal tumors with a PDGFRA D842V mutation.

The European Commission will now review CHMP's opinion and decide on marketing authorization by the end of September. If approved by the EC, avapritinib will be the first drug available for GIST patients in this molecularly defined indication in the European Union.

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