FDA Approves Adjuvant Pembrolizumab for the Treatment of Stage IIB/IIC Melanoma


Pembrolizumab has been approved by the FDA as an adjuvant treatment for patients with stage IIB or IIC melanoma.

The FDA has approved the use of adjuvant pembrolizumab (Keytruda) as a treatment for adult and pediatric patients aged 12 years or older who have been diagnosed with stage IIB or IIC melanoma after undergoing complete resection.

The drug’s efficacy was evaluated as part of the phase 3 KEYNOTE-716 (NCT03553846), which randomized patients to receive treatment with either 200 mg of pembrolizumab in the adult population and 2 mg/kg in the pediatric population every 3 weeks or placebo. Findings from the trial spotlighted a statistically significant improvement in relapse-free survival at the time of the first interim analysis among patients who were randomized to receive pembrolizumab vs placebo (HR, 0.65; 95% CI, 0.46-0.92; P = .0132).

The most common adverse effects were fatigue, diarrhea, pruritus, and arthralgia.


FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma. News release. FDA. December 3, 2021. Accessed December 3, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-stage-iib-or-iic-melanoma

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