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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 advanced melanoma, including a Phase III trial of MK-3475 versus ipilimumab in ipilimumab-naïve advanced melanoma patients (PN 006). Enrollment is complete in the advanced melanoma cohorts in the company’s Phase Ib trial (PN 001) and the Phase II trial (PN 002) comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy. In April 2013, Merck announced that MK-3475 received a Breakthrough Therapy designation for advanced melanoma from the FDA.

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