Merck: Keytruda Meets Key Endpoint in Stage II Resected Melanoma, Gets Priority Review

By Colin Kellaher

Merck & Co. on Thursday said a Phase 3 study of its blockbuster cancer drug Keytruda met its primary endpoint of recurrence-free survival for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma.

The Kenilworth, N.J., drugmaker said treatment with Keytruda as a single agent showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared with placebo as adjuvant therapy, with no new safety signals observed.

Merck said that based on the study data, the U.S. Food and Drug Administration accepted and granted priority review to an application for expanded approval of Keytruda as an adjuvant treatment of patients ages 12 and older with stage IIB or IIC melanoma following complete resection.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Merck said the agency set a target action date of Dec. 4 for the new indication.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is already approved for at least 30 indications in the U.S.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 05, 2021 08:06 ET (12:06 GMT)

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