Genentech made this decision following consultation with the U.S. Food and Drug Administration (FDA), in accordance with the requirements of the FDA's Accelerated Approval Program. The Phase III IMvigor130 trial was designed to evaluate Tecentriq plus platinum-based chemotherapy for the first-line treatment of people with previously untreated advanced bladder cancer. IMvigor130 was the designated postmarketing requirement (PMR) to convert the accelerated approval to regular approval, and it did not meet the co-primary endpoint of overall survival (OS) for Tecentriq plus chemotherapy compared with chemotherapy alone. These data will be presented at an upcoming medical meeting.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival.”This decision does not affect other approved indications for Tecentriq in the U.S.
Genentech will work with the FDA over the coming weeks to complete the withdrawal process and notify healthcare professionals in the U.S. about this withdrawal. Patients in the U.S. being treated with Tecentriq for previously untreated mUC should discuss their care with their healthcare provider.
Source: Genentech: Media. Available at: https://www.gene.com/media (Accessed: November 29, 2022).. Available at: https://www.gene.com/media (Accessed: November 29, 2022).