Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review
US drug giant Merck & Co (NYSE: MRK) says it has started a rolling submission to the US Food and Drug Administration of a Biologics License Application for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab.
A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. The company expects to complete the application in the first half of 2014.
This news, along with some on vorapaxar (see below), pushed Merck’s shares 6.6% higher to $53.19 in afternoon trading yesterday.
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