FDA Grants Accelerated Approval to Tecentriq-Abraxane Combo for Some TNBC

FDA Grants Accelerated Approval to Tecentriq-Abraxane Combo for Some TNBC
The U.S. Food and Drug Administration has granted accelerated approval to a combination of Tecentriq (atezolizumab) and the chemotherapy Abraxane (nab-paclitaxel) for patients with advanced triple-negative breast cancer, making this the first immunotherapy regimen approved specifically for breast cancer. The approval, which is for patients whose tumors produce the PD-L1 factor and are unable to receive surgery, was based on data from the IMpassion130 Phase 3 trial (NCT02425891), where the combination cut the risk of death or disease worsening by 40% compared to Abraxane only. Continued approval of this Tecentriq combination, like most accelerated approvals, is contingent on additional data confirming that the approach also brings overall survival benefits. The agency also approved the Ventana PD-L1 Assay as a companion diagnostic device for selecting triple-negative breast cancer eligible for the combination treatment. “The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” Sandra Horning, MD, chief medical officer and head of global product development, said in a press release. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.” Tecentriq, developed by Genentech, is an immune checkpoint inhibitor meant to block signals from cancer cells that impair the immune system from doing its job. It binds to the PD-L1, produced by cancer cells, and prevents its binding to the PD-1 receptor on immune cells. It is approved for some patients with bladder or non-small cell lung cancer.
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