Breaking News, Trials & Filings

Merck Files Rolling BLA for anti-PD-1 Treatment

Filing covers advanced melanoma, expected to be complete in 1H14

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Merck has begun a rolling submission to the FDA of a BLA for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab (Bristol-Myers Squibb‘s Yervoy). 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 1H14. MK-3475 is currently being studied in three clinical trials for ad...

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