✦ On Aug. 17, 2018, the FDA gave accelerated approval to Bristol-Myers Squibb Co.’s programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) for the treatment of people with metastatic small cell lung cancer whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy (RSP 9/18, p. 8). That approval was based on surrogate endpoints from the Phase I/II CheckMate -032 trial. However, the subsequent trials CheckMate -451 and CheckMate -331 did not meet their primary endpoints of overall survival, so in consultation with the FDA, the company has withdrawn this indication from the U.S. market. Bristol-Myers is advising people being treated with Opdivo for this indication to consult with their health care provider. Visit https://bit.ly/3o2gNlN.
✦ Pfizer Inc. launched its granulocyte colony-stimulating factor Nyvepria (pegfilgrastim-apgf) in the U.S. on Dec. 15 following its June 10, 2020, approval (RSP 7/20, p. 8), according to AmerisourceBergen Corp. It is the fourth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) on the U.S. market, joining Mylan N.V.’s Fulphila (pegfilgrastim-jmdb), Coherus BioSciences, Inc.’s Udenyca (pegfilgrastim-cbqv) and Ziextenzo (pegfilgrastim-bmez) from Sandoz Inc., a Novartis AG unit. Visit www.nyvepria.com and view AmerisourceBergen’s biosimilars pipeline report at https://bit.ly/3mZwYPD.