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July 29, 2021

Merck’s Keytruda Gets the Nod in Early Triple-Negative Breast Cancer

The FDA has approved the neoadjuvant use of Merck’s pembrolizumab (Keytruda) in combination with chemotherapy for patients with breast cancer and as a single-agent adjuvant treatment after surgery. The FDA approval is intended for the treatment of triple-negative breast cancer (TNBC), an aggressive form of the disease with an increased risk of recurrence. Roughly 10-15 percent of patients with breast cancer are diagnosed with TNBC. 

The combination therapy marks the first time that a treatment regimen including immunotherapy has been approved for patients with early stage TNBC. FDA had previously declined to approve the drug, , but subsequently approved it less than three months later following receipt of more data.