FDA Accepts BLA for Advanced Melanoma Therapy
Merck announced that the FDA has accepted for review the Biologics License Application (BLA) for MK-3475, an investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA has also granted Priority Review to the BLA.
The MK-3475 development program is currently ongoing in 30 tumor types as monotherapy and in combination. It is anticipated that by the end of 2014, the MK-3475 development program will grow to more than 24 clinical trials across 30 different tumor types, enrolling an estimated 6,000 patients, including four new Phase 3 studies.
Ongoing and planned late-stage monotherapy and combination studies include seven Phase 3 registrational trials with advanced melanoma (adjuvant, ipilimumab-naïve, and ipilimumab-refractory), advanced non-small cell lung cancer (NSCLC) (previously-treated and previously-untreated), advanced head & neck cancer and advanced bladder cancer; and ten combination studies, including advanced melanoma, advanced NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other solid tumors.
Previously, the FDA had granted MK-3475 Breakthrough Therapy designation for advanced melanoma. If approved, MK-3475 would be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.
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