Merck’s cancer immunotherapy Keytruda (pembrolizumab) has become the first drug of its kind to be approved for early triple-negative breast cancer after a previous rejection from the FDA for the indication in March due to lack of data.

The FDA greenlighted the immunotherapy drug for patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, then continued as a single-agent adjuvant treatment after surgery.

The combination is “the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community,” said Vicki Goodman, vice president of clinical research at Merck.