FDA Approves Merck’s Keytruda as Adjuvant Treatment for Serious Melanoma

The FDA has handed another approval to Merck’s blockbuster cancer drug Keytruda (pembrolizumab), this time as an adjuvant treatment for adults and children 12 years and older with stage IIB or IIC melanoma following surgery.

The approval was supported by interim phase 3 data that showed Keytruda reduced recurrence of disease or death by 35 percent vs. placebo.

A monoclonal antibody, Keytruda is an anti-PD-1 therapy that strengthens the immune system’s ability to find and attack tumor cells. Merck earned worldwide revenue of $14.4 billion from the drug in 2020, a 30 percent increase year-over-year.