Merck Gets FDA Priority Review of Keytruda in Classical Hodgkin Lymphoma

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.

https://www.marketscreener.com/MERCK-CO-INC-13611/news/Merck-Gets-FDA-Priority-Review-of-Keytruda-in-Classical-Hodgkin-Lymphoma-30898737/