News Briefs

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-331 did not meet their primary endpoints of overall survival, so in consultation with the FDA, the company has withdrawn this indication from the U.S. market.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.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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