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FDA Agrees to Review Antibody Therapy MK-3475 for Advanced Melanoma

Approval decision expected in October

The FDA has accepted for review the biologics license application for MK-3475 (Merck), an investigational anti–PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been treated with ipilimumab (Yervoy, Bristol-Myers Squibb).

The FDA granted the treatment a “priority review” designation, with a Prescription Drug User Fee Act (PDUFA) date of October 28, 2014. The agency previously granted MK-3475 a “breakthrough therapy” designation for advanced melanoma, the most dangerous type of skin cancer. If approved, MK-3475 would be the first anti–PD-1 antibody in a new class of immune checkpoint modulators.

The MK-3475 clinical development program currently involves use of the drug in 30 tumor types as monotherapy or as a part of combination treatments.

Ongoing and planned late-stage studies include seven phase III registrational trials in subjects with advanced melanoma (adjuvant, ipilimumab-naïve, and ipilimumab-refractory); with advanced non–small-cell lung cancer (NSCLC) (previously treated and previously untreated); with advanced head-and-neck cancer; or with advanced bladder cancer.

The development program for MK-3475 also includes ten studies of combination treatments in patients with advanced melanoma, advanced NSCLC, advanced renal-cell carcinoma, HER2-positive breast cancer, and other solid tumors.

More than 15 company-sponsored abstracts on MK-3475 will be presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting.

Source: Merck; May 6, 2014.

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