After Bladder Cancer, Roche Pulls Breast Cancer Indication For Tecentriq In US

Following a consultation from the FDA, Roche Holdings AG RHHBY has decided to withdraw its immunotherapy, Tecentriq (atezolizumab), to treat a type of breast cancer in the U.S.
Earlier this year, Roche withdrew the drug from the U.S. to treat bladder cancer after follow-up studies failed to meet goals.
Related Content: Roche Walks Away From Regular FDA Nod For Tecentriq In Pretreated Bladder Cancer.
The drug received accelerated approval for metastatic triple-negative breast cancer (mTNBC) in 2019 but failed to deliver positive follow-up data required by the agency.
Tecentriq was approved in combination with Abraxane for unresectable locally advanced or mTNBC expressing PD-L1.
Due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval, the company said, citing it as the reason for the voluntary withdrawal.
The decision does not affect other approved indications for Tecentriq in the U.S.
Related content: Benzinga's Full FDA Calendar
Price Action: RHHBY shares are up 1.13% at $50.19 during the market session on the last check Friday.