Roche announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, or nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1, as determined by an FDA-approved test.
The ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for atezolizumab in this indication.
“People with triple-negative breast cancer have few treatment options, which is why today's committee decision to recognize the importance of this atezolizumab combination is significant,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
The FDA's Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements to confirm the clinical benefit and convert to regular approval.
Atezolizumab is a monoclonal antibody designed to bind with PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.
The combination treatment was granted accelerated approval in March 2019 for the treatment of adults with PD-L1–positive, unresectable locally advanced or metastatic triple-negative breast cancer based on the positive progression-free survival results from the IMpassion130 study. Continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement for the metastatic triple-negative breast cancer indication.
IMpassion131 did not meet its primary endpoint of progression-free survival for the first-line treatment of people with metastatic triple-negative breast cancer in the PD-L1–positive population. However, the clinically meaningful benefit demonstrated in the IMpassion130 study remains, so the manufacturer will continue to work with the FDA to determine next steps for the combination in this indication.
