) 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
). 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
) - a Zacks Rank #2 (Buy) stock.
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