FDA Approves Keytruda for Melanoma Patients After Tumor Resection

Source: Immuno-Oncology News, March 2019

The U.S. Food and Drug Administration has approved the use of Keytruda(pembrolizumab) as a treatment for melanoma patients with stage 3 disease — cancer cells have spread to the lymph nodes but not to distant organs — who have undergone complete resection of a tumor.

The approval is based on data from the KEYNOTE-054 Phase 3 trial (NCT02362594), where Keytruda treatment reduced the risk of disease recurrence or death by 43% compared to a placebo.

“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 III melanoma,” Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a press release. “At Merck, we are committed to transforming the treatment of cancer, as is exemplified by this important advance in the adjuvant treatment of melanoma.”