BioCentury
ARTICLE | Regulation

Dec. 1 Quick Takes: broader label for Blueprint; plus Minerva, Biohaven-Sosei, Genetron, PegBio, drug imports 

December 2, 2020 2:32 AM UTC

Blueprint gains broader FDA label for Gavreto
FDA approved Gavreto pralsetinib from Blueprint Medicines Corp. (NASDAQ:BPMC) to treat advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive, radioactive iodine-refractory thyroid cancer in patients at least 12 years of age. The approval brings Gavreto, which was first approved in September to treat RET-positive non-small cell lung cancer (NSCLC), into the same set of indications as competing RET inhibitor Retevmo selpercatinib from Eli Lilly and Co. (NYSE:LLY). In July, Blueprint partnered with Roche (SIX:ROG; OTCQX:RHHBY) to develop and commercialize Gavreto.

FDA skeptical of Minerva’s submission plans
Minerva Neurosciences Inc. (NASDAQ:NERV) believes published guidance and precedents support moving ahead with an NDA submission for roluperidone to treat negative symptoms in schizophrenia. The company said FDA believes a submission based on current Phase IIb and Phase III data “would be highly unlikely to be filed,” in part because the ex-U.S. former study did not use the candidate’s commercial formulation, while the latter trial failed to separate from placebo in the intent-to-treat analysis. Still, Minerva intends to “continue to move forward with the clinical pharmacology, non-clinical, and CMC work” to support a submission. Minerva slipped $1 (26%) to $2.89 on Tuesday...