Genentech/Roche will voluntarily withdraw the FDA accelerated approval for Tecentriq + chemo to treat triple-negative breast cancer.

Genentech made this decision following consultation with the FDA based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval program. This decision only impacts the mTNBC indication in the U.S. It does not affect other approved indications for Tecentriq in the U.S. and outside the U.S., including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Approval was based on the progression-free survival (PFS) results of the Phase III IMpassion130 study for people with mTNBC whose tumors express PD-L1 ( greater than 1%). Continued approval for this indication was contingent upon the results of IMpassion131, the post marketing requirement (PMR). This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. The results of both studies were discussed at the FDA Oncology Drugs Advisory Committee (ODAC), which voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq in combination with nab -paclitaxel for the treatment of people with PD-L1-positive mTNBC.

Since then, Genentech has been working diligently with the FDA on a possible alternative PMR. However due to the 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. mTNBC indication.

Genentech will work with the FDA over the coming weeks to complete the withdrawal process. Genentech is notifying healthcare professionals in the U.S. about this withdrawal. Patients in the U.S. being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider. Patients, or their healthcare 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. Our patient support specialists can help answer questions, including insurance coverage and potential financial assistance options.