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Vemurafenib New Drug Application Submitted to FDA for Melanoma
Date:5/11/2011

d by other promising molecules from our robust pipeline."

About the Vemurafenib Clinical Program

The submissions are based on results from two clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma, as determined by the cobas 4800 BRAF V600 Mutation Test.  

Earlier this year, Plexxikon reported positive data from an interim analysis of BRIM3, which showed that the study met the pre-specified criteria for co-primary endpoints for BRIM3 for progression free survival and overall survival (OS), and that the safety profile was generally consistent with the previous vemurafenib studies.  Based on these results, the data safety monitoring board for the trial recommended early termination of the trial and allowed dacarbazine-treated patients to immediately cross over to vemurafenib treatment. BRIM2 results reported earlier showed a 52 percent confirmed response rate, with tumor shrinkage in the majority of patients, consistent with results from earlier studies.

The most frequent Grade 3 adverse event observed in clinical trials of vemurafenib was cutaneous squamous cell carcinoma, a common skin cancer treated by local excision (minor surgery done in a physician's office).  The most common adverse events were rash, increased sun sensitivity, joint pain, hair loss and fatigue.  Possible serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats, and allergic reactions.

Comprehensive data from BRIM3 will be presented at a plenary session at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June.  Additionally, updated BRIM2 data also will be presented at ASCO.

About Melanoma

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 p
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SOURCE Daiichi Sankyo, Inc.
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