29 March 2021 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics license application seeking approval for Keytruda, the company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as neo-adjuvant (pre-operative) treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery. 

Merck is reviewing the letter and will discuss next steps with the FDA.

Read Merck press release