FDA Approves Adjuvant Keytruda for Pediatric and Adult Melanoma


The FDA approved adjuvant Keytruda for patients ages 12 and older with stage 2b, 2c or 3 melanoma that has been completely resected.

The Food and Drug Administration (FDA) approved adjuvant Keytruda (pembrolizumab) for the treatment of adults and children over the age of 12 who have stage 2b, 2c or 3 melanoma that was fully resected. The FDA also expanded Keytruda’s indication as adjuvant treatment for stage 3 melanoma that has been completely resected, according to Merck, the manufacturer of the immunotherapy agent.

“The standard of care for patients with resected stage 2b and 2c melanoma has been observation, despite the fact that for these patients, the risk of recurrence is nearly the same as for patients with later-stage disease for whom treatment is recommended,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center in a statement. “Today’s approval of (Keytruda) for the adjuvant treatment of patients 12 years and older with stage 2b and 2c melanoma following complete resection is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning.”

The stage 2b and 2c approvals are based on findings from an interim analysis of the phase 3 KEYNOTE-716 clinical trial, which showed that Keytruda improved recurrence-free survival (RFS), with a 35% reduction in the risk of recurrence or death compared to placebo. Average RFS was not reached for either group. At an average follow-up of 14.4 months, 11% of patients in the Keytruda arm and 17% of patients on the placebo arm died or had their disease recur.

The drug’s effectiveness in pediatric patients with stage 2b, 2c and 3 was supported by extrapolation of efficacy data from the adults because the disease’s biology, drug effectiveness and exposure-response is similar between the groups.

Side effects – particularly immune-mediated adverse reactions – from Keytruda can be severe or life-threatening, and can occur any time during or after receiving the drug. Patients should talk with their clinicians about side effects they are experiencing, with notable toxicities being: colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

If side effects are particularly bad, it may lead to pausing or permanently discontinuing Keytruda.

“Keytruda was the first anti-PD-1 therapy to be approved in metastatic melanoma in the U.S. seven years ago. Since then, we have built on this foundation in melanoma and have expanded the use of Keytruda into earlier stages of this disease,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “With today’s approval, we can now offer healthcare providers and patients 12 years and older the opportunity to help prevent melanoma recurrence with Keytruda across resected stage 2b, stage 2c and stage 3 melanoma.”

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