Skip to NavigationSkip to content

New Keytruda dosing schedule rejected in six cancers by the FDA

Published on 20/02/20 at 12:08pm

MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application for a new dosing regimen in six different cancers: melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

The therapy is already approved in those cancers when taken at 200mg dose every three weeks; the manufacturer was seeking to add the new dosing schedule of 400mg every six weeks on the grounds that it would provide patients with greater flexibility and make their trips to receive infusion more infrequent.  

Keytruda already secured approval in Europe for this dosing regimen on the back of positive data. However, the FDA met these same data with a Complete Response Letter, explaining that it could not approve the drug. In response, MSD confirmed it was “reviewing” the letter “and will discuss next steps with the FDA”.

Matt Fellows

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches