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26 Apr 2013

New melanoma treatment given Breakout Therapy status by FDA

Merck is celebrating after its new melanoma treatment was given Breakout Therapy status by the FDA

New York-based pharmaceutical company Merck is celebrating after the US Food and Drink  Administration (FDA) named its lambrolizumab treatment a Breakthrough Therapy for patients suffering from advanced melanoma.
The company, which is known as MSD outside of North America, developed the drug with the aim of offering patients being treated for melanoma and other types of tumours an advanced form of antibody therapy.
Now, following the positive results from a series of medical trials published in November of last year, the company has confirmed that federal regulators have formally signalled that its latest product has significant potential in this field.
Welcoming the development, Merck senior vice president Gary Gilliand said: " The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone for Merck as we advance ongoing programs in multiple cancer indications."
According to European health authorities, one in six melanoma cases are only detected once the tumour is in its advanced stages, with failing to cover up in the sun blamed for a significant proportion of all cases.

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