Pharmaceutical company withdraws Tecentriq regimen for metastatic breast cancer
Pharmaceutical company Genentech is voluntarily withdrawing the fast-track approval of Tecentriq (atezolizumab) plus chemotherapy to treat patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
Approval was initially granted by the Food and Drug Administration (FDA) in March 2019, based on the results of the Phase 3 trial IMpassion130. The continued approval of the regimen – which consists of Tecentriq plus Abraxane, albumin-bound paclitaxel or nab-paclitaxel – was based on trial follow-up data.
Subsequent findings showed that Tecentriq plus chemotherapy did not meet the primary endpoint of progression-free survival (PFS) in the first-line treatment of mTNBC patients whose tumors were PD-L1 positive. Despite this, in April of this year, the FDA’s Oncology Drugs Advisory Committee (ODAC) voted 7-2 to maintain the fast-track approval of Tecentriq plus nab-paclitaxel.
However, after Genentech and the FDA reviewed other FDA-approved treatments for this patient population, Genentech decided to withdraw the approval altogether.
“TNBC remains the most difficult type of breast cancer to treat, which makes the decision to opt out so difficult for us, as patients have had this drug as an important option for over 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 healthcare teams. If they have any questions, they should contact the Genentech Patient Resource Center at 877-436-3683.
The approvals of Tecentriq in other types of cancer, such as lung cancer, skin cancer, certain subsets of bladder cancer and liver cancer, are still valid and are not affected by the revocation of the mTNBC indication.
This isn’t the first fast-track approval to be withdrawn this year. In March, one of Tecentriq’s regimens for bladder cancer was withdrawn by the FDA, as was Opdivo for liver cancer in July.
“We appreciate the opportunity to have been able to help people with mTNBC in the United States with Tecentriq throughout the expedited approval process, which has brought many important and new therapies to patients,” Garraway said. “We remain committed to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
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