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.
New research led by Friends of Cancer Research demonstrates that decreases in circulating tumor DNA after initiation of treatment are associated with improved overall survival in patients with advanced non-small cell lung cancer treated with immunotherapy or chemotherapy.
