Genentech Voluntarily Withdraws Atezolizumab FDA Accelerated Approval For PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Atezolizumab was granted accelerated approval for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting.

Following an assessment of the current treatment landscape, Genentech has voluntarily withdrawn its FDA accelerated approval of atezolizumab in combination with chemotherapy for the treatment of programmed death-ligand 1 (PD-L1)-positive, metastatic triple-negative breast cancer (mTNBC).

According to a press release, this decision comes after an FDA assessment of the current mTNBC treatment landscape and in accordance with requirements of the accelerated approval program. The withdrawal does not impact other approved indications for atezolizumab, including in mTNBC, and does not reflect any changes in the efficacy or safety data.

“TNBC 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, in the press release.

Atezolizumab was granted accelerated approval for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. The approval was based on progression-free survival (PFS) data from the phase 3 IMpassion 130 study of patients with mTNBC whose tumors express PD-L1.

Continued approval was contingent upon the results from the IMpassion131 trial, which did not meet its primary endpoint of PFS for the first-line treatment of individuals with mTNBC in the PD-L1-positive population. Both trial results were discussed by the FDA Oncology Drugs Advisory Committee in April 2021, although the committee voted to maintain the accelerated approval.

Since this decision, officials at Genentech have worked with FDA experts on a possible alternative postmarketing requirement, since IMpassion 131 failed to meet its primary endpoint. However, the press release said that due to recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval status.

“We appreciate the opportunity to have been able to help people with mTNBC in the US with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients,” Garraway said in the press release. “We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”

REFERENCE

Genentech Provides Update on Tecentriq US Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer. News release. Genentech; August 27, 2021. Accessed September 1, 2021. https://www.gene.com/media/press-releases/14927/2021-08-27/genentech-provides-update-on-tecentriq-u