New Drug Applications Submitted for Vemurafenib Market Approval in Melanoma
Berkeley, CA — May 10, 2011 — Plexxikon Inc., a member of the Daiichi Sankyo Group, today announced that applications for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, a pre-marketing application for approval for a companion diagnostic test has been submitted in the U.S.; the test also will be registered in Europe. Vemurafenib is an oral drug that selectively targets the BRAF V600 mutation, which occurs in about half of all cases of melanoma and eight percent of all solid tumors. The companion diagnostic determines whether a patient’s tumor tests positive for the BRAF mutation and is eligible to receive vemurafenib treatment.
Current studies of vemurafenib are being conducted by Roche, Plexxikon’s co-development partner under a 2006 collaboration agreement, and Genentech, Roche's U.S. oncology unit. Roche has submitted applications with the health authorities for market approval for both vemurafenib and the companion diagnostic. Additional clinical trials are planned, including combinations with other approved drugs and investigational agents, as well as in other cancers. During the marketing application review period, vemurafenib is available to eligible patients with BRAF V600 mutation-positive melanoma through a global patient access program. More information about this program or other vemurafenib studies is available at www.clinicaltrials.gov (in the U.S.) or www.clinicaltrialsregister.eu or on the Roche Clinical Trials Registry at www.roche-trials.com (in the EU). Genentech can also be contracted by calling the company’s clinical trial call center at 888-662-6728 or emailing email@example.com.
Melanoma is the most serious type of skin cancer and is growing at a rate of about five to six percent annually. More than 70,000 people in the U.S. and 160,000 people worldwide are diagnosed with melanoma each year. It is one of the deadliest cancers, with a five-year survival rate of 15 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.
About Vemurafenib (PLX4032)—A Personalized Medicine for Cancer Treatment
Vemurafenib is a novel, oral small molecule for treating melanoma and other cancers harboring the oncogenic BRAF mutation. Plexxikon utilized its structure-guided chemistry platform to discover vemurafenib, and initiated clinical development in 2006. Plexxikon and Roche signed a license and collaboration agreement in 2006 to co-develop vemurafenib. Under a 2005 agreement, a DNA-based companion diagnostic to identify patients whose tumors carry the BRAF mutation is being co-developed by Roche Molecular Systems and Plexxikon in parallel with the therapeutic development of vemurafenib.
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s lead compound, vemurafenib (PLX4032), is in late-stage clinical trials for the treatment of melanoma, and the subject of recent applications for marketing approval in the U.S. and Europe. PLX3397, the company’s next oncology candidate, has advanced to Phase 2 testing in 2011. The company is developing a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in oncology, as well as in several other therapeutic indications. Plexxikon’s proprietary Scaffold-Based Drug Discovery™ platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches.
In April 2011, Daiichi Sankyo acquired Plexxikon. Plexxikon continues research and development operations as an independent unit of and member of the Daiichi Sankyo Group. Under Plexxikon’s U.S. co-promotion agreement with Genentech signed in 2010, Daiichi Sankyo, Inc. will co-promote vemurafenib, subject to market approval by FDA.