Merck’s Keytruda snags inaugural approval in U.K.’s early-access scheme

Merck’s ($MRK) Keytruda may still be waiting for regulatory approval in Europe, but some patients will soon have access to the therapy thanks to a new program in the U.K.

 

On Wednesday, the country’s Medicines and Healthcare Products Regulatory Agency announced it had cleared the immunotherapy to treat advanced melanoma patients who have failed on other treatments, Reuters reports. It’ll make the treatment available under the U.K.’s Early Access to Medicines program, which fast-tracks products to help patients with severe illnesses and no other treatment options.

Keytruda is now the first therapy available under the drug-company-funded scheme, and the early-access approval makes Keytruda the first checkpoint inhibitor available on the continent. That’s a title it boasts in the U.S., too, where it snagged FDA approval last September.

But Keytruda already has competition at home–and it’s competition that’s already blown by it to snag another indication. After winning the agency’s favor in melanoma in December, Bristol-Myers’ ($BMY) Opdivo last week grabbed a non-small cell lung cancer nod. And that’s an indication analysts say will prove much more lucrative–think $21 billion in potential sales by 2022 for the class, versus a $3 billion opportunity in melanoma.

That’s not to say Merck’s out of the lung cancer race. On the contrary, the pharma giant plans to file for approval midway through this year, CEO Ken Frazier said in January. And Bernstein analyst Tim Anderson, for one, has predicted Keytruda could arrive on the scene with a broader NSCLC label than Opdivo’s, which could help it pick up some ground.

http://www.fiercepharma.com/story/mercks-keytruda-snags-inaugural-approval-uks-early-access-scheme/2015-03-11?utm_medium=nl&utm_source=internal

 

 

 

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