FDA Approves Immunotherapy Regimen for Breast Cancer
March 2019 ~
For the first time, the combination of immunotherapy and chemotherapy has been given FDA approval for certain patients with metastatic triple-negative breast cancer.
According to the press release, the FDA has 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.
As stated in the release, this indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.
The FDA’s decision was based on the results from a study of 902 women that showed improvement in two areas with the new treatment. The first, “progression-free survival”, which measured how long a patient lives after they start treatment without the tumor getting worse, and the second, “overall survival”, measured how long a patient lives after treatment starts.
“The Tecentriq regimen is an exciting new treatment option for certain people living with metastatic triple-negative breast cancer, a difficult-to-treat form of the disease,” Hayley Dinerman, executive director of the Triple Negative Breast Cancer Foundation, said in an statement. “Chemotherapy alone has been the mainstay of treatment for many years, so it’s encouraging to now have an immunotherapy combination available for people with PD-L1-positive disease.”