FDA has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Application seeking approval for Keytruda, Merck’s 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 neoadjuvant treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.
“We’ve always argued that money comes and goes, but if you lose a generation of scientists—you can’t buy them back,” said Kelvin Lee, director of the Indiana University Simon Comprehensive Cancer Center.
