The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Gavreto is FDA-approved for RET-altered thyroid cancers
FDA has indicated Gavreto (pralsetinib) from Blueprint Medicines to treat adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The drug was formerly known as BLU-667 and won FDA approval in September 2020. CStone, which is developing the drug in China, received approval from that country’s regulatory authority, making it the first novel therapy for…
Ayvakit wins approval for advanced systemic mastocytosis
Ayvakit from Blueprint Medicines Corp. was initially FDA-indicated to treat adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. In June, the drug won expanded use to include advanced systemic mastocytosis based on data from the single-arm, open-label EXPLORER and PATHFINDER clinical studies.…