NEW YORK (TheStreet) -- Skin cancer patients in Britain can be treated with Merck's (MRK) - Get Report Keytruda before the cancer immunotherapy drug is approved there under a new early access plan announced Wednesday.
Keytruda is the first medicine accepted under the United Kingdom's Early Access to Medicines Scheme. The U.K.'s version of the FDA started the program last year to help patients benefit from promising drugs before they're granted approval in Europe.
Last October, Keytruda received a "Promising Innovative Medicine" designation from the U.K., which was the first step necessary before early access to the drug could be granted.
Merck will provide Keytruda for free to eligible skin cancer patients in the U.K., the company said. Keytruda is already approved in the U.S. to treat skin cancer and is under regulatory review in Europe. Bristol-Myers Squibb's (BMY) - Get ReportOpdivo, a cancer immunotherapy similar to Keytruda, is also approved in the U.S. to treat skin cancer and a certain type of lung cancer.
Both Keytruda and Opdivo work by blocking a protein known as PD-1, which cancer cells use to hide from a patient's immune system. Blocking PD-1 makes tumors visible to killer T cells.
Merck is the first company to be granted early access for an unapproved drug in the U.K., but it's not the first to try. Last September, Northwest Biotherapeutics (NWBO) announced that its experimental brain tumor vaccine DCVax-L had also received "Promising Innovative Medicine" status from U.K. regulators.
At that time, Northwest said it was working toward getting DCVax-L available to brain cancer patients under the early access program. There's been no update from Northwest since last September about whether U.K. officials have reviewed DCVax-L for early access.
Coincidentally, it was also one year ago that Northwest said German regulators cleared DCVax-L for compassionate use through a program known as "Hospital Exemption." But as in the U.K., Northwest's follow-through in Germany has been slack. Company promises to finalize compassionate use pricing and reimbursement for DCVax-L in Germany have not materialized yet.
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