merckincweb

New Keytruda dosing schedule rejected in six cancers by the FDA

pharmafile | February 20, 2020 | News story | Sales and Marketing Cancer, FDA, MSD, keytruda, pharma 

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

Related Content

Rethinking oncology trial endpoints with generalised pairwise comparisons

For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …

brain_anatomy_medical_head_skull_digital_3_d_x_ray_xray_psychedelic_3720x2631_1

Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation

Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …

drug-trials

LGC Group opens $100M Organic Chemistry Synthesis Centre of Excellence

LGC Group, a life sciences company, has opened its new Organic Chemistry Synthesis Centre of …

The Gateway to Local Adoption Series

Latest content



Pace appoints Ken Beyer as CEO

December 10, 2025