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FDA Approves Merck's KEYTRUDA To Treat High-Risk Early-Stage Triple-Negative Breast Cancer

The U.S. Food and Drug Administration has approved Merck & Co., Inc.'s (MRK) anti-PD-1 therapy, KEYTRUDA, for the treatment of patients with high-risk early-stage triple-negative breast cancer or TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, Merck said in a statement.

TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence.

The phase 3 KEYNOTE-522 trial result showed that KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS) versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC - there was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause.

KEYTRUDA is now approved in the U.S. for 30 indications.

According to the company, Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.

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