FDA Grants Keytruda Priority Review for Melanoma


The PDUFA date for this indication is December 4, 2021.

The FDA has accepted Merck’s supplemental biologics application (sBLA) and granted Priority Review for Keytruda (pembrolizumab) as an adjuvant treatment for adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma. Keytruda is already approved to treat patients with resected stage III melanoma.

This application is based on the phase 3 KEYNOTE-716 trial in which Keytruda met its primary end point of recurrence-free survival (RFS). At an interim analysis, treatment with Keytruda as a single agent showed a statistically significant and clinically meaningful improvement in RFS compared with placebo as adjuvant therapy for these patients. No new safety signals were observed. Merck officials said results will be presented at an upcoming medical meeting.

Jason Luke, M.D.

Jason Luke, M.D.

“KEYNOTE-716 is the first phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma, an area with high unmet need,” Jason Luke, M.D., director of the Cancer Immunotherapeutics Center at the UPMC Hillman Cancer Center in Pittsburgh, said in a prepared statement from Merck. “By moving immunotherapy with Keytruda to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared with observation alone following complete resection.”

Melanoma is the fifth most common cancer. According to National Cancer Institute, incidence estimates, 106,000 new cases will be diagnosed this year in the U.S. The death rate was 2.3 per 100,000 men and women per year. These rates are age-adjusted and based on 2014 to 2018 cases and deaths.

Melanoma is more common in men than in women and among individuals of fair complexion and those who have been exposed to natural or artificial sunlight (such as tanning beds) over long periods of time.

The list price for each indicated dose of Keytruda when given every three weeks is $10,067.36. The list price for each indicated dose of KEYTRUDA when given every 6 weeks is $20,134.72, according to Merck.

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