Manufacturer Withdraws Atezolizumab from FDA Accelerated Approval for Triple-negative Breast Cancer

By Andrew John, Pharm /alert Contributor
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Genentech has voluntarily withdrawn the accelerated approval of atezolizumab (Tecentriq) combined with albumin-bound paclitaxel as a first-line treatment for patients with locally advanced or metastatic PD-L1-positive, triple-negative breast cancer, the company announced in a press release.

“TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the announcement. “We appreciate the opportunity to have been able to help people with mTNBC in the U.S. with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”

The FDA granted the drug accelerated approval for metastatic triple-negative breast cancer in March of 2019. That approval, however, hinged upon the progression-free survival (PFS) of patients enrolled in the phase 3 IMpassion130 study. The study failed to meet its primary outcome of PFS in patients with metastatic PD-L1-positive, triple-negative breast cancer.

The company said it consulted with the FDA on changing this requirement, which is known as the postmarketing requirement.

“However due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval. This led to the difficult decision to voluntarily withdraw the U.S. mTNBC indication,” the press release from Genentech said.

The statement did not provide details on which changes in the treatment landscape prompted the decision.

The withdrawal of the drug applies only to the indication in the United States for metastatic PD-L1-positive, triple-negative breast cancer, the company said, and not for other diseases, or for countries outside of the U.S. Further, the withdrawal “is not related to any changes in either the efficacy or safety associated with Tecentriq,” according to the press release.

 

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