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The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application (NDA) for avapritinib (Ayvakit) as a treatment for adult patients with fourth-line gastrointestinal stromal tumor (GIST). The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020, according to BluePrint Medicines, the developer of avapritinib.

The presence of the proteins p16 and p21 has shown to be predictive of treatment response in patients with osteosarcoma, a disease that previously had no identified biomarkers to indicate whether or not patients would benefit from therapy, explained C. Parker Gibbs, MD.

The FDA has granted an accelerated approval to tazemetostat (Tazverik) for the treatment of adult and pediatric patients aged ≥16 years old with metastatic or locally advanced epithelioid sarcoma that is not eligible for complete resection.

The FDA has approved avapritinib (Ayvakit) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.