Roche has announced its decision to withdraw its US accelerated approval for its immuno-oncology drug Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) where tumours express PD-L1.
The decision was made in consultation with the Food and Drug Administration based on its “assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme”.
In a statement, Roche stressed that its decision only impacted the mTNBC indication in the US and was not related to any changes in efficacy or safety.
Triple-negative breast cancer is an aggressive, difficult-to-treat form of the disease that doesn’t respond to hormonal or targeted therapies. 15% of the 2 million women diagnosed with breast cancer each year have TNBC, which is more common in women under the age of 50. TNBC patients generally experience rapid progression and shorter overall survival compared to other subtypes of breast cancer.
Merck’s Keytruda and Bristol Myers Squibb’s Opdivo also had accelerated approvals questioned this year, as part of a larger review of accelerated approvals by the regulator. In July, the FDA gave full approval to Keytruda in both advanced/metastatic and in early-stage TNBC.
The accelerated approval for Tecentriq was granted in 2019 but was contingent on the success of the IMPASSION-131 study. However, even though the study did not meet its primary endpoint of progression-free survival for first-line treatment in PD-L1-positive mTNBC, the FDA’s Oncology Drugs Advisory Committee voted 7 to 2 in favour of maintaining the accelerated approval in late April 2021.
However, with Keytruda fully approved for the indication, the FDA no longer “considers it appropriate” to maintain the accelerated approval, said Roche.
“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 Roche chief medical officer and head of global product development, Levi Garraway. “We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
Other immuno-oncology drugs with accelerated approval have also been withdrawn this year: BMS withdrew Opdivo in liver cancer, Merck pulled Keytruda in gastric cancer, and AstraZeneca withdrew Imfinzi in bladder cancer, all in the US only.