Tecentriq plus chemotherapy did not meet the determined progression-free survival goal, so Genentech – the manufacturer of the immunotherapy agent – decided to pull the indication.
The pharmaceutical company Genentech is voluntarily withdrawing accelerated approval of Tecentriq (atezolizumab) plus chemotherapy to treat patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
The approval was originally granted by the Food and Drug Administration (FDA) in March 2019, based on findings from the phase 3 IMpassion130 trial. Continued approval of the regimen – which consists of Tecentriq plus Abraxane, albumin-bound paclitaxel or nab-paclitaxel – relied on follow-up data from the trial.
Later findings showed that Tecentriq plus chemotherapy did not meet the primary endpoint of progression-free survival (PFS) in the frontline treatment of patients with mTNBC whose tumors were PD-L1 positive. Despite this, in April of this year, the FDA Oncology Drugs Advisory Committee (ODAC) voted 7 to 2 in favor of keeping the accelerated approval of Tecentriq plus nab-paclitaxel.
However, after Genentech and the FDA reviewed other FDA-approved treatments for this patient population, Genentech decided to pull the approval altogether.
“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 Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech, in a statement.
Patients with PD-L1-positive mTNBC who are being treated with the Tecentriq-chemo regimen should discuss next steps with their health care teams. If they have any questions, they should reach out to the Genentech Patient Resource Center at 877-436-3683.
Tecentriq’s approvals in other cancer types, such as lung cancer, skin cancer, certain bladder cancer subsets and liver cancer, still stand and are not affected by the revoking of the mTNBC indication.
“We appreciate the opportunity to have been able to help people with mTNBC in the U.S. with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients,” Garraway said. “We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
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