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.
With the fiscal year drawing to a close, grant funding from NCI is picking up speed, offering a glimmer of hope to cancer researchers who are beginning to feel cautiously optimistic about the road ahead.
