Blueprint Medicines Announces PDUFA Date Extension for New Drug Application of Avapritinib for the Treatment of Adults with Fourth-Line Gastrointestinal Stromal Tumor
Blueprint Medicines Corporation, a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its New Drug Application (NDA) seeking accelerated approval of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST). The FDA extended the PDUFA action date by three months from February 14, 2020 to May 14, 2020.
As previously announced, the FDA has requested top-line data from Blueprint Medicines’ ongoing Phase 3 VOYAGER clinical trial, which is comparing avapritinib to regorafenib in third- or fourth-line GIST, to inform the pending action on the NDA for fourth-line GIST. Blueprint Medicines expects to provide the top-line data to the FDA early in the second quarter of 2020 to enable the FDA to take action by the May 14, 2020 PDUFA date.
In addition, Blueprint Medicines today announced that the National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma to include avapritinib as a recommended category 2A treatment for unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, as well as fourth-line GIST. This rating indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Guidelines are the recognized clinical standard for cancer care by U.S. healthcare providers and payers, and are maintained by a committee of expert physicians from leading U.S. cancer centers.
Read the full press release here.