Companion test case
Roche's BRAF, Daiichi's Zelboraf put companion diagnostic model to test
FDA's approval of Zelboraf vemurafenib and the cobas 4800 BRAF V600 Mutation Test from Roche marks the first time since 1998 that the agency has simultaneously approved a drug and a companion diagnostic. The next step will be to see how effectively the pharma and partner Daiichi Sankyo Co. Ltd. will be able to market the combination for melanoma.
Zelboraf's label specifies use of an FDA-approved test to identify patients who are eligible for treatment. But unless payers force them to use Roche's test, doctors at several large institutions told BioCentury they would prefer to use CLIA tests performed in their own facilities because they are faster and are run by familiar and trusted pathologists.
FDA approved Zelboraf on Aug. 17 - two and a half months ahead of the Oct. 28 PDUFA date - to treat unresectable or metastatic melanoma with BRAF V600E mutation. On the same day,