August 27, 2021
1 min read
Genentech has decided to voluntarily withdraw its accelerated approval of atezolizumab plus nab-paclitaxel for treatment of PD-L1-positive, unresectable locally advanced or metastatic triple-negative breast cancer.
The decision follows an FDA assessment of changes in the treatment landscape for metastatic triple-negative breast cancer that led the agency to determine it is no longer appropriate to maintain accelerated approval, granted in March 2019, according to a Genentech-issued press release. The withdrawal is not due to any changes in safety or efficacy associated with atezolizumab (Tecentriq, Genentech), according to the manufacturer.
‘[Triple-negative breast cancer] 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 2 years,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in the press release. “We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in [metastatic triple-negative breast cancer].”
The combination of atezolizumab, an anti-PD-L1 monoclonal antibody, and nab-paclitaxel (Abraxane, Celgene) received accelerated approval based on improved PFS observed in the phase 3 IMpassion130 study. However, the confirmatory IMpassion131 trial did not meet its primary endpoint of PFS for the first-line treatment of patients with PD-L1-positive metastatic triple-negative breast cancer.
Despite this, members of the FDA Oncologic Drugs Advisory Committee voted 7-2 in April to keep the combination on the market for this patient population, in part due to a lack of effective therapies for this indication.
Genentech had been working with the FDA on a possible alternative postmarketing requirement and now will work with the agency to complete the withdrawal process, according to the press release. The move affects only the U.S. indication for atezolizumab in metastatic triple-negative breast cancer.
Atezolizumab is approved for several other indications, including treatment of certain patients with lung cancer, hepatocellular carcinoma and melanoma. In March, Genentech voluntarily withdrew atezolizumab’s U.S. indication for patients with platinum-treated metastatic urothelial carcinoma.