Zelboraf vemurafenib regulatory update

Chugai said Japan approved Zelboraf vemurafenib to treat unresectable melanoma with a BRAF V600 mutation. The company also said Japan approved Roche’s cobas 4800 BRAF V600 Mutation Test as a companion diagnostic for Zelboraf -- an oral small molecule inhibitor of the oncogenic BRAF V600E -- to identify patients with metastatic melanoma tumors with a mutation in the BRAF gene. The PCR-based nucleic acid test is approved in the EU and U.S. ...