Genentech Medicine FDA Approved as First Cancer Immunotherapy for a Type of Breast Cancer
March 8th, 2019
On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
News in brief
- This Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer.
- Testing for PD-L1 can help identify people that may benefit from treatment with this Tecentriq combination.
- Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. TNBC is an aggressive form of the disease with few treatment options.
Supporting Information
"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. 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.”