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US FDA approves Merck’s new injectable version of Keytruda

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(Reuters) – The U.S. Food and Drug Administration has approved a new formulation of Merck’s blockbuster cancer therapy Keytruda that can be administered under the skin, offering a more convenient option of the widely used cancer immunotherapy, the health regulator said on Friday.

The new version, branded as Keytruda Qlex, marks a major shift in how one of the world’s best-selling cancer drugs is administered, giving a faster alternative to the traditional intravenous method and shortening the time patients spend receiving the cancer immunotherapy.

The under-the-skin version cuts down time to be administered in one minute if dosed every three weeks or in two minutes if dosed every six weeks, said Nancy Ibach, associate vice president of US Oncology at Merck, compared to about 30 minutes for the IV infusion.

Keytruda, approved in 2014, harnesses the body’s own immune system to fight cancers with dramatic results. It is approved for multiple cancer types and generated nearly $30 billion in sales in 2024.

(Reporting by Kamal Choudhury and Sriparna Roy in Bengaluru; Editing by Maju Samuel)

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