More Cancer Indications With Accelerated Approval Are Being Withdrawn

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.

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Angela Maas

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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