FDA approves expanded indication for Merck's Keytruda

The US Food and Drug Administration has approved an expanded indication for Merck’s (NYSE: MRK) Keytruda (pembrolizumab) to include the first-line treatment of patients with unresectable or metastatic melanoma.

The drug becomes the first anti-PD-1 Therapy to be approved for previously untreated advanced melanoma patients regardless of BRAF status.

The expanded approval was based on the results of the KEYNOTE-006 Phase III trial which revealed that patients given 10mg/kg of Keytruda every two weeks demonstrated a 35% reduction in the risk of death compared to ipilimumab. Those given 10mg/kg Keytruda every three weeks demonstrated a 31% reduction in the risk of death.