Keytruda combo approved for high-risk early-stage triple-negative breast cancer

27 July 2021

US pharma giant Merck & Co’s (NYSE: MRK) blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has won US regulatory approval for yet another cancer indication.

The Food and Drug Administration has approved Keytruda for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial.

The decision comes a few months after the FDA declined to approve the drug for these cancer patients, after an expert panel recommended that .a decision on approval should be delayed until more data is available.

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