Atezolizumab TNBC Indication Withdrawn By Manufacturer After Talks With FDA


Atezolizumab will no longer be available for the treatment of patients with PD-L1–positive triple-negative breast cancer following withdrawal of the indication by the agent’s developer.

The indication for atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) chemotherapy as treatment for patients with triple-negative breast cancer (TNBC) whose tumors express PD-L1 has been withdrawn by Roche, the company responsible for agent, following consultation with the FDA.

These discussions were part of an industry-wide effort by the FDA to reassess the status of systemic therapy agents granted accelerated approval whose confirmatory trials did not indicate a clinical benefit to treatment.

“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 two years,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “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. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”

Accelerated approval was granted to atezolizumab in March 2019 based on data from the phase 3 IMpassion130 trial (NCT02425891) which demonstrated a statistically significant benefit to progression-free survival with the exploratory regimen vs placebo/chemotherapy (HR, 0.60; 95% CI, 0.48-0.77; P <.0001).2

Continued approval of the agent was contingent upon results of the IMpassion131 trial (NCT03125902).3 However, results published in Annal of Oncology in 2021 indicated that the trial failed to meet the primary end point of PFS superiority in the frontline treatment of patients with PD-L1 positivity (HR, 0.82; 95% CI, 0.60-1.12; P = .20). Additionally, there was no difference in survival advantage in the PD-L1–positive (HR 1.11, 95% CI 0.76-1.64) nor the intention to treat population.

The Oncology Drugs Advisory Committee (ODAC) decided in a 7 to 2 vote to maintain the accelerated approval of atezolizumab in April 2021, with the agency and drug maker working in tandem to institute a potential alternative pre-market requirement. However, the FDA has since reconsidered the appropriateness of this accelerate approval.


  1. Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer. News release. Roche. August 27, 2021. Accessed August 27, 2021.
  2. FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. FDA. March 8, 2019. Accessed August 27, 2021.
  3. Miles D, Gligorov J, André F, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021;32(8):994-1004. doi:10.1016/j.annonc.2021.05.801
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