Vemurafenib, a new melanoma drug, has submitted a listing application to FDA and EMA

It is reported that Vemurafenib is a novel oral drug that targets oncogene BRAF mutations in about half of melanoma cancers and about 8% of all solid tumors. Japan’s First Sankyo Co., Ltd. has submitted a listing application for the drug to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval for the treatment of metastatic melanoma. The company also submitted a pre-marketing application with the diagnostic test to FDA, which will be registered in Europe.

In April 2011, First Sankyo Co., Ltd. acquired Plexxikon. At that time, Plexxikon developed Vemurafenib and is working with Roche to develop the drug. According to the joint promotion agreement between Plexxikon and Roche's Genentech, First Sankyo Co., Ltd. will jointly promote Vemurafenib with Genotech in the United States.

Dr. Glenn Gormley, chairman and chief science officer of the Drug Development Department of First Tri-Comm Corporation, said that after discovering Vemurafenib only six years later, he submitted a new drug application to the FDA, which shows that Plexxikon’s research platform for identifying unique molecules is highly efficient and its team The early development policy is strategic. For this reason, the first three were proudly to take it as their own, to jointly provide new drugs for patients.

John Gargiulo, president and chief executive officer of First Sankyo Co., Ltd., said that the company’s experienced sales team is ready to go with Jetan Technology Corp. to jointly promote Vemurafenib in the United States pending FDA approval. They look forward to working with partners to provide new personalized methods for fatal cancer patients and suppliers. Vemurafenib is likely to be the company’s first product to enter the oncology market, and they are very fortunate and excited about this. They hope to subsequently introduce other potential molecular products through their powerful pipelines.