U.S. FDA approves Merck immune-stimulating drug for melanoma

Sept 4 Thu Sep 4, 2014 2:56pm EDT

Sept 4 (Reuters) - U.S. regulators on Thursday approved the use of Merck & Co Inc's immuno-oncology drug Keytruda, also known as pembrolizumab, as a treatment for patients with advanced melanoma who are no longer responding to other therapies.

The drug is the first in a promising new class designed to help the body's own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.

Melanoma, the deadliest form of skin cancer, is diagnosed in around 76,000 Americans each year and around 10,000 will die from the disease annually, according to the National Cancer Institute.

The FDA said in a statement that clinical trials of Keytruda showed that it shrank tumors in around 24 percent of patients with advanced melanoma whose disease worsened after prior treatment.

The agency had designated Keytruda as a "breakthrough therapy," and approved the drug nearly two months ahead of an Oct. 28 decision deadline. (Reporting By Deena Beasley; Editing by Bernard Orr)

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After wave of QE, onus shifts to leaders to boost economy

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