Xiya Reagent:new trial underscores our commitment to researching

This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are excited to partner with Merck and explore the potential of talimogene laherparepvec and KEYTRUDA. This will also give us insights into talimogene laherparepvec beyond the monotherapy setting, where a Phase 3 trial has shown encouraging results."

"Merck is advancing the study of immuno-oncology combinations with KEYTRUDA across a broad range of malignancies," said Dr.Eric Rubin, vice president, Clinical Development for Oncology, Merck Research Laboratories. "We are pleased to collaborate with Amgen to evaluate the potential of KEYTRUDA and talimogene laherparepvec as a combination regimen for the treatment of advanced melanoma."

A Biologics License Application has recently been accepted for review by the FDA as has a Marketing Authorization Application in the European Union for talimogene laherparepvec for the treatment of patients with regionally or distantly metastatic melanoma. FDA has set a review goal date under the Prescription Drug User Fee Act (PDUFA) of July 28, 2015.

The regulatory filings included data from more than 400 patients and is based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of intralesional talimogene laherparepvec in patients with stage IIIB, IIIC, or IV melanoma that are not surgically resectable compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). An Amgen-sponsored expanded access protocol (EAP) is currently active for qualified patients with unresected, stage IIIB to IV melanoma who are not eligible for or who cannot access ongoing talimogene laherparepvec trials.· 以上资料由西亚试剂：http://www.xiyashiji.com/ 提供此产品的详细信息如密度,含量,分子式,分子量等均可在西亚官网查询