FDAnews
www.fdanews.com/articles/199575-merck-gains-expanded-indication-for-hodgkin-lymphoma-drug
Merck_logo.jpg

Merck Gains Expanded Indication for Hodgkin Lymphoma Drug

October 16, 2020

Merck’s Keytruda (pembrolizumab) has received an expanded indication from the FDA for the treatment of adults with classical Hodgkin lymphoma (cHL) after frontline therapy and for children with refractory or relapsed cHL, following two or more lines of therapy.

The approval was supported by results from a phase 3 trial in which the treatment significantly reduced the risk of cancer spread or death by 35 percent vs. control. Patients receiving Keytruda had an average survival time of five months longer.

The blockbuster drug has also received approval from Health Canada as a monotherapy for adult patients with recurrent head and neck squamous cell carcinoma.

Keytruda earned more than $11 billion in global revenues in 2019.

View today's stories