MRK Merck and Co Inc

   By Colin Kellaher 
 

Merck & Co. (MRK) on Monday said the Food and Drug Administration accepted a supplemental Biologics License Application for its Keytruda cancer drug as adjuvant therapy in patients with resected, high-risk stage III melanoma, the most serious form of skin cancer.

The Kenilworth, N.J., drug maker said the sBLA is based on a significant benefit in recurrence-free survival shown by Keytruda in a pivotal Phase 3 trial.

Keytruda, a new type of cancer drug that harnesses patients' immune systems to fight tumors, is already marketed to treat lung, skin, bladder and other cancers.

Merck said the FDA set a target action date of Feb. 16, 2019 for the sBLA.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 25, 2018 07:06 ET (11:06 GMT)

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