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FDA grants priority review to Merck’s cancer antibody

Will speed up assessment of MK-3475 in skin cancer melanoma
FDA grants priority review to Merck's cancer antibody

Merck & Co's promising cancer antibody MK-3475 has continued its impressive development run by gaining priority review from the US FDA for use in the treatment of the skin cancer melanoma.

The designation, which adds to the breakthrough therapy designation already attributed to MK-3475, is reserved for new therapies that offer significant improvements in the safety or effectiveness of the treatment of serious conditions and aims to shorten the FDA review period from 10 months to six.

Merck filed a Biologics License Application for the anti-PD-1 antibody at the beginning of the year for use in patients with advanced melanoma who have previously been treated with Bristol-Myers Squibb's (BMS) Yervoy (ipilimumab), which is emerging as the standard of care in melanoma.

The application followed some exciting early clinical trials, including a phase 1b trial published at the end of last year in which more than 80 per cent of advanced melanoma patients treated with MK-3475 were still alive after one year.

Such results offer significant improvement over current melanoma therapies, and Merck has great expectations for a drug many believe can reach multibillion sales at peak.

The latest news from the FDA continues to back this belief and puts MK-3475 on course to be the first anti-PD-1 antibody approved in the US. 

Other investigational medicines in this category include Bristol-Myers Squibb's nivolumab, Roche's MPDL3280A and AstraZeneca's MEDI4736 and MEDI0680, all of which are currently in clinical trials in a range of cancers, although have yet to be filed with any regulator. Novartis also recently joined the field with its purchase of CoStim.

In addition to announcing the priority review status of MK-3475, Merck also confirmed that it plans to file the drug in the EU by the end of the year for use in advanced melanoma.

Merck's ambitions extend further than the use of the drug in melanoma though, and the company has clinical trials ongoing for its use in non-small cell lung cancer (NSCLC).

Merck has also signed agreements with rivals Pfizer, Amgen and Incyte to test MK-3475 in combination with other oncology drugs across a variety of cancers.

7th May 2014

From: Sales



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