Merck and Co. has begun submitting an application to federal regulators for approval of an experimental cancer drug to treat melanoma, a process expected to be completed in the first half of 2014.
The submission is a big priority for the Hunterdon County pharmaceutical company as it seeks to replenish its pipeline after several patent expirations on blockbuster drugs.
The drug, MK-3475, is part of a class of drugs known as anti-PD-1 immunotherapies, which treat cancer by stimulating the body's immune system.
Merck is doing so via a rolling submission, which allows completed portions of the application to be reviewed by the U.S. Food and Drug Administration on an ongoing basis.
Roger Perlmutter, president of Merck Research Laboratories, said patients of advanced melanoma currently have limited treatment options. MK-3475, which was designated a “breakthrough therapy” by the FDA, is currently being studied in three clinical trials.
“Initiation of this rolling submission represents an important milestone in the MK-3475 clinical development program for patients suffering from malignant melanoma,” Perlmutter said in a statement Monday.
Merck is undergoing a company-wide restructuring, which includes cutting jobs, refocusing its investments and relocating its headquarters to Kenilworth by 2015.
As part of that restructuring, Merck also said Monday it will decide this year the fate of its animal health and consumer care businesses, which analysts have speculated could be spun off or divested. Merck has said those units make money for the company, but it will continue exploring strategic options.
“The company expects to complete the process and take action, if any, in 2014,” Merck said.