FDA Approves Neoadjuvant Pembrolizumab Combination for Early TNBC Indication

Published by W Butcher on

The FDA granted approval to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as neoadjuvant therapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) when given in combination with chemotherapy followed by single-agent use after surgery, according to the company responsible for the PD-1 inhibitor, Merck.1 This decision by the FDA was supported by data from the phase 3 KEYNOTE-522 trial (NCT03036488) which examined the neoadjuvant regimen in the indicated patient population versus matched placebo and demonstrated a statistically significant event-free survival (EFS) benefit (HR, 0.63; 95% CI, 0.48-0.82; P = .00031) with active versus control therapy. “Even when TNBC is diagnosed early, 30% to 40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery,” Joyce O’Shaughnessy, MD, chair of Breast Cancer Research at Baylor University Medical Center of Texas Oncology, U.S. Oncology in Dallas, Texas, said in a press release. “Therefore, there is a high unmet need for new treatment options. Today’s approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC.”

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