MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment

Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks the 39th indication for MSD’s top-selling drug in the United States.

The authorization was granted based on positive Phase III clinical trial data, which demonstrated that the combination therapy reduced the risk of disease progression or death by 41% compared to a placebo plus chemoradiotherapy control group. At the time of the data cut-off, the median progression-free survival (PFS) for the treatment group had not been reached, indicating the potential for significant benefits in patient outcomes.- Flcube.com

Fineline Info & Tech