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.
The Cancer Letter has covered—and will continue to cover—all the ways in which the current administration is fundamentally reshaping cancer research in the U.S. But this week, The Cancer Letter and the podcast focused on a patient story.
