Meghna Trivedi, MD
Three classes of drugs have demonstrated promising outcomes in patients with metastatic triple-negative breast cancer (TNBC), and phase III data and longer follow-up are anticipated to determine how these agents can be best utilized in this space, explained Meghna Trivedi, MD.
First, 2 PARP inhibitors have been added to the TNBC armamentarium for patients with BRCA
-mutant tumors. Olaparib (Lynparza) was approved by the FDA in January 2018 for the treatment of patients with germline BRCA
-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy. In October 2018, the agency approved talazoparib (Talzenna) for patients with deleterious or suspected deleterious germline BRCA
-mutated, HER2-negative locally advanced or metastatic breast cancer.
Immunotherapy has also shown clinical activity in patients with PD-L1–positive TNBC. Results of the phase III IMpassion130 trial showed that the addition of atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) reduced the risk of disease progression or death by 38% versus nab-paclitaxel alone in patients with unresectable locally advanced or metastatic PD-L1–positive TNBC.1
Based on these data, the FDA granted a priority review designation to a supplemental biologics license application for the frontline atezolizumab regimen in this patient population. Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the approval by March 12, 2019.
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