FDA Approves Keytruda for High-Risk, Advanced Melanoma

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) — an immunotherapy agent – for the adjuvant treatment of patients with resected, high-risk, stage 3 melanoma, according to Merck, the manufacturer of the immunotherapy agent.

The approval is based off the promising findings from the phase III EORTC 1325-MG/KEYNOTE-054 trial, which compared Keytruda to placebo and proved that the PD-1 inhibitor reduced risk of recurrence or death by 43 percentfor patients with resected, high-risk, advanced melanoma. Prior to approving the agent, the FDA granted Keytruda a supplemental biologics license application (sBLA) in this setting in June of 2018. An sBLA occurs when the manufacturer of a drug applies to market it in a different setting than it is already being used.

“It is great to have another anti-PD1 immunotherapy option to consider for patients with resected melanoma who remain at risk of recurrence,” said Michael A. Postow, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center, in an interview with CURE.

Patients were randomly selected to receive either Keytruda or placebo. After receiving surgery, study participants received 200 mg of either Keytruda or saline drip on day 1 of each 21-day cycle for 18 cycles (about one year) until disease recurrence or unacceptable toxicity.

Keytruda, like other anti-PD-1/PD-L1 therapies, can come with an array of side effects that patients should look out for.

Severe side effects can include: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Keytruda should be withheld or discontinued and corticosteroids administered if appropriate. The drug can also cause severe or life-threatening infusion-related reactions.

“In the fight against cancer, progress is made one step at a time, and today we’re pleased to take another important step — making Keytruda available as an adjuvant therapy for patients with stage 3 melanoma,” said Roy Baynes, M.D., Ph.D., senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a statement. “At Merck, we are committed to transforming the treatment of cancer, as is exemplified by this important advance in the adjuvant treatment of melanoma.”