Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoints and have yet to gain regular approvals.
Atezolizumab is a monoclonal antibody designed to bind with the protein PD-L1, expressed on tumor cells and tumor-infiltrating immune cells, thereby blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the reactivation of T cells.
The FDA’s Accelerated Approval Program allows 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 was granted accelerated approval in 2016 for the treatment of prior platinum-treated metastatic urothelial carcinoma based on the results from the IMvigor210 study (cohort 2). Continued approval for this indication was contingent upon the results of IMvigor211, the original postmarketing requirement for the prior platinum-treated metastatic urothelial carcinoma indication. This study did not meet its primary endpoint of overall survival in the PD-L1–high patient population. Subsequently, the FDA designated the IMvigor130 study as the postmarketing requirement, which will continue until the final analysis. However, as the treatment landscape in second-line metastatic urothelial carcinoma has rapidly evolved with the emergence of new treatment options, Genentech is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.
Genentech will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for atezolizumab.
Genentech is notifying health-care professionals about this withdrawal. Patients being treated with atezolizumab for prior platinum-treated metastatic urothelial carcinoma should discuss their care with their health-care provider.
