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Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer


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Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with 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 a U.S. Food and Drug Administration (FDA)-approved test. Genentech made the decision following consultation with the FDA, based on the agency’s assessment of the current metastatic triple-negative breast cancer treatment landscape and in accordance with the requirements of the accelerated approval program.

This decision only impacts the metastatic triple-negative breast cancer indication in the United States; it does not affect other approved indications for atezolizumab in the U.S. and outside the U.S., including metastatic triple-negative breast cancer. This is not related to any changes in either the efficacy or safety associated with atezolizumab.

“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,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Genentech and Roche. “We appreciate the opportunity to have been able to help people with metastatic triple-negative breast cancer in the U.S. with atezolizumab 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 atezolizumab in metastatic triple-negative breast cancer.”

Atezolizumab is a monoclonal antibody designed to bind to PD-L1 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 reactivation of T cells.

Accelerated Approval

Atezolizumab was granted accelerated approval by the FDA for the metastatic triple-negative breast cancer indication in March 2019, making it the first immunotherapeutic agent to be approved in this setting. Approval was based on the progression-free survival results from the phase III IMpassion130 study for people with metastatic triple-negative breast cancer whose tumors express PD-L1 (≥ 1%).

Continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement. This study 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.

The results of both studies were discussed at the FDA Oncology Drugs Advisory Committee, which voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of atezolizumab in combination with nab-paclitaxel for the treatment of people with PD-L1–positive metastatic triple-negative breast cancer. Since then, Genentech has been working diligently with the FDA on a possible alternative postmarketing requirement. However, due to 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. metastatic triple-negative breast cancer indication.

Genentech will work with the FDA over the coming weeks to complete the withdrawal process, and the company is notifying health-care professionals in the United States about this withdrawal. Patients in the U.S. being treated with atezolizumab for PD-L1–positive metastatic triple-negative breast cancer should discuss their care with their health-care provider.

Patients or health-care providers who have questions or concerns about coverage, reimbursement, or out-of-pocket costs are encouraged to call the Genentech Patient Resource Center at (877) 436-3683 for assistance; patient support specialists can help answer questions, including insurance coverage and potential financial assistance options.


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