Blueprint Medicines Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). The CRL states that the FDA cannot approve the application. Ayvakit will continue to be available for metastatic PDGFRA Exon 18 patients including PDGFRA D842V mutations
The Life Raft Group has been engaged in extensive discourse with Blueprint Medicines and our Medical Advisory Team to evaluate further action we can consider in light of this unfortunate decision.
Read the press release here.
See Patient information at YourBlueprint