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.
Sidney Kimmel Cancer Center at Jefferson Health can add the word “Comprehensive” to its name, becoming the 57 institution to earn this top-level designation from NCI. xxx:more
