Merck: Keytruda Meets Key Endpoint in Stage II Resected Melanoma, Gets Priority Review
August 05 2021 - 8:15AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 05, 2021 08:06 ET (12:06 GMT)
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