Aug. 7, 2018 /PRNewswire/
Array BioPharma today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI™), in combination with binimetinib (MEKTOVI®) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease.
BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation,
and currently there are
<no therapies specifically approved for this high unmet need population.>
Breakthrough Therapy指定：
エンコラフェニブ(ONO-7702)＋ビニメチニブ（ONO-7703)
Aug. 7, 2018 /PRNewswire/
Array BioPharma today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI™), in combination with binimetinib (MEKTOVI®) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease.
BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation,
and currently there are
<no therapies specifically approved for this high unmet need population.>