EMA committee recommends approval for injectable version of Merck’s Keytruda

Audio By Carbonatix

Enlarge

(Reuters) – The European Medicines Agency’s committee has recommended approval for a new formulation of Merck’s blockbuster cancer therapy Keytruda that can be administered under the skin, the U.S. drugmaker said on Friday.

An approval would allow patients to access a faster alternative to the traditional intravenous method, reducing the time required to receive cancer immunotherapy — a treatment Merck has long relied on to fuel growth.

Keytruda, approved in the U.S. in 2014, harnesses the body’s own immune system to fight cancers.

The U.S. Food and Drug Administration is also expected to decide on the application for the subcutaneous or injectable version this month. It has set an action date of September 23.

The under-the-skin version cuts down time to be administered in one minute every three weeks for 395 mg dose or in two minutes every six weeks for 790 mg dose, the company said.

The injectable version potentially offers more options for patients to receive their treatment as it allows healthcare providers to deliver the therapy in a variety of settings.

The recommendations made by the EMA’s Committee for Medicinal Products for Human Use will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway.

Final decisions are expected in the fourth quarter of 2025.

The committee also recommended approval of Keytruda as part of a perioperative regimen for the treatment of certain adult patients with a type of advanced head and neck cancer.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)