Roche said it made this decision following consultation with the U.S. Food and Drug Administration (FDA), based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the agency’s accelerated approval program. This decision only impacts the mTNBC indication in the United States. It does not affect other approved indications for Tecentriq in the U.S. and outside the U.S., including mTNBC.
“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
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 (≥1%). Continued approval for this indication was contingent upon the results of IMpassion131, the post-marketing requirement (PMR).
Roche said the 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, Roche said it has been working 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.
