FDA Approves Pembrolizumab for New Breast Cancer Indication

The FDA approved Merck's blockbuster cancer drug, pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).

“Today’s approval is a significant milestone, as it represents the first approval for Keytruda in the breast cancer setting,” said Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, in a press release.

In the phase 3 trial supporting the approval, Keytruda in combination with paclitaxel, nab-paclitaxel or gemcitabine and carboplatin, significantly improved progression-free survival for patients with advanced triple-negative breast cancer whose tumors express PD-L1 with combined positive score (CPS) greater than or equal to 10 compared with the same chemotherapy regimens alone, Baynes added.

Keytruda, in combination with the chemotherapy agents, reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone.

Continue reading on Formulary Watch to learn more.