FDA approves Keytruda for adjuvant treatment of melanoma with involvement of lymph node(s) following complete resection. Merck Inc.

Merck Inc., announced that the FDA has approved Keytruda, Merck�s anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial.

This pivotal Phase III trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), demonstrated that Keytruda significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in patients with resected, high-risk stage III melanoma (HR=0.57 [95% CI, 0.46, 0.70]; p<0.001). keytruda is the first anti-pd-1 therapy studied in the adjuvant setting across patients with stage iiia (>1 mm lymph node metastasis) IIIB and IIIC melanoma.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, keytruda should be withheld or discontinued and corticosteroids administered if appropriate. Keytruda can cause fetal harm when administered to a pregnant woman.