Manufacturer Withdraws Atezolizumab’s U.S. Indication in Triple-Negative Breast Cancer
Posted: Tuesday, August 31, 2021
Genentech has decided to voluntarily withdraw the U.S. accelerated approval for its PD-L1 inhibitor atezolizumab (Tecentriq) in combination with chemotherapy for adults with unresectable locally advanced or metastatic triple-negative breast cancer with PD-L1 expression. The U.S. Food and Drug Administration (FDA) had previously granted accelerated approval for atezolizumab in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer based on the results of the IMpassion130 trial. However, continued approval was contingent on favorable results in the phase III IMpassion131 study.
The decision impacts atezolizumab’s breast cancer indication in the United States. It does not affect the European Commission’s atezolizumab plus nab-paclitaxel approval for metastatic triple-negative breast cancer whose tumors express PD-L1. Additionally, the withdrawal does not impact other approved indications for atezolizumab.
In the IMpassion130 trial, patients administered the combination treatment showed significant improvement in progression-free survival and clinically meaningful improvement in overall survival compared with patients who were given chemotherapy alone. However, follow-up data from the IMpassion131 study did not meet its primary endpoint for using atezolizumab as a first-line treatment in metastatic triple-negative breast cancer with PD-L1 expression. The study failed to show significant improvement in both progression-free and overall survival.
The FDA’s Oncologic Drugs Advisory Committee had initially voted to uphold atezolizumab’s accelerated approval in a 7 to 2 decision. However, the FDA supports Genentech’s decision to withdraw atezolizumab’s breast cancer indication voluntarily. Health-care professionals should consider alternative treatment options for any patients currently taking atezolizumab for PD-L1–positive metastatic triple-negative breast cancer.
