Roche is voluntarily withdrawing the indication for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, paclitaxel bound to albumin [human]; nab-paclitaxel) in the United States (US) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1), as determined by a Food and Drug Administration (FDA)-approved test.
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, plus Abraxane for unresectable locally advanced or metastatic TNBC based on progression free survival results from the phase 3 IMpassion130 study (ClinicalTrials.gov Identifier: NCT02425891). According to the FDA’s accelerated approval program, a drug may be approved earlier if it is intended to treat a serious condition or fills an unmet need; the approval is based on a surrogate end point that is thought to predict clinical benefit.
However, findings from the subsequent confirmatory phase 3 IMpassion131 study (ClinicalTrials.gov Identifier: NCT03125902) showed that treatment with Tecentriq did not meet the primary endpoint of progression free survival in adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1. Continued approval for the indication was contingent upon the results of the IMpassion131 study.
The Company will be working with the FDA in the coming weeks to complete the withdrawal process. The withdrawal of the Tecentriq indication does not affect its use outside the US, along with other FDA approved indications for Tecentriq. Patients who are receiving Tecentriq for PD-L1-positive unresectable locally advanced or metastatic TNBC should consult with their health care provider.
“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, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer. News release. Hoffmann-La Roche Ltd. Accessed August 30, 2021. https://www.globenewswire.com/news-release/2021/08/27/2287799/0/en/Roche-provides-update-on-Tecentriq-US-indication-for-PD-L1-positive-metastatic-triple-negative-breast-cancer.html.