Merck Gets FDA Priority Review of Keytruda in Classical Hodgkin Lymphoma
July 09 2020 - 7:29AM
Dow Jones News
By Colin Kellaher
Merck & Co. on Thursday said the U.S. Food and Drug
Administration granted priority review for the expanded use of its
cancer drug Keytruda as second-line treatment for adults with
relapsed or refractory classical Hodgkin lymphoma.
The Kenilworth, N.J., drug maker said its application is based
on data from a Phase 3 study in which Keytruda showed a significant
improvement in progression-free survival compared to brentuximab
vedotin, a current standard of care in this patient population.
Merck said classical Hodgkin lymphoma accounts for more than 90%
of cases of Hodgkin lymphoma, which affects about 7,400 patients a
year in the U.S.
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 to
six months from the standard 10 months. Merck said the agency set a
target action date of Oct. 30 for the application.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 09, 2020 07:14 ET (11:14 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024
