Plexxikon Inc., a member of the Daiichi Sankyo Group, today announced
that applications for market approval for vemurafenib ( PLX4032/RG7204, see below structure)
for the treatment of metastatic melanoma have been submitted to the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency
(EMA). The company had
Phase 2 and 3 trials (BRIM2 and BRIM3) that evaluated vemurafenib in patients with BRAF V600 mutation-positive melanoma, as determined by the cobas 4800 BRAF V600 Mutation
Test.
Earlier this year, the company 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, 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.
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