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Will Merck's Anti-PD-1 Therapy be the First to Launch?

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Merck’s (MRK) promising immuno-oncology candidate, pembrolizumab (MK-3475), has been accepted for review in the EU -- timely approval would make pembrolizumab the first anti-PD-1 therapy to gain approval in Europe. The company is looking to get the experimental anti-PD-1 antibody approved for the treatment of advanced melanoma.

Melanoma, the most dangerous type of skin cancer, is the 19th most common cause of cancer death in Europe.

According to the press release issued by Merck, about 22,200 deaths in Europe in 2012 were due to malignant melanoma. The five-year survival rate for advanced melanoma patients is less than 20% - as a result, new and additional treatment options are needed to treat the disease.

Pembrolizumab is currently under review in the U.S. as well where a response from the FDA should be out by Oct 28.  Pembrolizumab has Breakthrough Therapy designation for advanced melanoma in the U.S. and FDA approval this October would make it the first anti-PD-1 therapy to be approved in the country. Merck is evaluating pembrolizumab for more than 30 types of cancer alone and in combination with other therapies.

Immuno-oncology is an area which has been attracting a lot of interest in recent times with several companies pursuing the development of these candidates alone or in collaboration with others. Immuno-oncology therapies have the potential to change the treatment paradigm for cancer -- they use the natural capability of the patient's own immune system to fight the cancer.

Apart from Merck, major players in this field include Bristol-Myers Squibb (BMY) and Roche (RHHBY). However, Merck could well have a head-start in this field if pembrolizumab gains FDA approval this year.

Merck is a Zacks #3 (Hold) stock. A better-ranked stock in the health care sector is Allergan (AGN) – a Zacks Rank #2 (Buy) stock.

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