Gastrointestinal stromal tumor (GIST) targeted new drugs! Avapritinib will be approved in the EU in September
Blueprint Medicines announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting conditional approval of the targeted anticancer drug avapritinib as a monotherapy for Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) carrying platelet-derived growth factor receptor alpha (PDGFRA) gene D842V mutation.
Now, the positive opinions of the CHMP will be reviewed by the European Commission (EC), which is expected to make a final review decision at the end of September. If approved, Avapritinib will become the first targeted therapy in the European Union for patients with GIST with PDGFRA D842V mutation, and will be commercialized under the brand name Ayvakyt. Avapritinib is a kinase inhibitor that has been approved by the US FDA in January this year under the brand name Ayvakit for the treatment of unresectable or metastatic GIST adult patients with PDGFRA gene exon 18 mutations (including PDGFRA D842V mutations).
It is worth mentioning that Avapritinib is the first precision therapy approved for GIST and the first drug with high activity against GIST with a mutation in exon 18 of the PDGFRA gene. In mid-May of this year, Avapritinib's fourth-line treatment for GIST was rejected by the FDA.