Another Immunotherapy Indication Will Be Withdrawn

September 9

The seventh indication since late December for an immunotherapy is being withdrawn from the U.S. market. All of the indications were granted through accelerated approval. All of the affected therapies have other FDA-approved indications.

On Aug. 27, Genentech USA, Inc., a member of the Roche Group, said it will voluntarily withdraw the accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test. It does not impact other approved indications for Tecentriq in the U.S. or TNBC approvals outside the U.S. The FDA gave the drug accelerated approval for TNBC on March 8, 2019.

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Radar on Specialty Pharmacy

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (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.