Another Immunotherapy Indication Will Be Withdrawn

The seventh indication since late December for an immunotherapy is being withdrawn from the U.S. market.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.

AIS Health Staff

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