Pembrolizumab Plus Chemotherapy Receives Accelerated Approval in Triple-Negative Breast Cancer
Posted: Monday, November 16, 2020
On November 13, the U.S. Food and Drug Administration (FDA) moved from Priority Review to accelerated approval of the pembrolizumab (Keytruda) in combination with chemotherapy for locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1, as determined by an FDA approved test. The FDA also approved the companion diagnostic, PD-L1 IHC 22C3 pharmDx, for selecting patients with triple-negative breast cancer for pembrolizumab.
The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks administered prior to chemotherapy until disease progression, unacceptable toxicity, or up to 24 months. Additionally, protein-bound paclitaxel at 100 mg/m2 on days 1, 8, and 15 every 28 days, paclitaxel at 90 mg/m2 on days 1, 8, and 15 every 28 days, or gemcitabine at 1,000 mg/m2 plus carboplatin AUC 2 mg/mL/min on days 1 and 8 every 21 days can be given with pembrolizumab via an intravenous infusion.
The FDA approval was based on the results of the multicenter KEYNOTE-355 trial. The study selected patients with locally recurrent unresectable or metastatic triple-negative breast cancer who had not been previously treated with chemotherapy in the metastatic setting. Patients were randomly assigned to receive 200 mg of pembrolizumab on day 1 every 3 weeks or a placebo in combination with different chemotherapy treatments via intravenous infusion. Patients in the pembrolizumab-plus-chemotherapy arm had a median progression-free survival of 9.7 months compared with the 5.6 months observed in the placebo arm (one-sided P = .0012).
The most common adverse reactions observed in 20% or more of patients in the pembrolizumab arm included fatigue, nausea, diarrhea, constipation, vomiting, alopecia, rash, cough, decreased appetite, and headache.
For full prescribing information on pembrolizumab, visit accessdata.fda.gov.