The Food & Drug Administration has the right to be proud of two landmark companion diagnostic approvals in the oncology area this year: Pfizer Inc. ’s Xalkori with an Abbott Laboratories Inc.Vysis FISH Probe Kit for lung cancer and Zelboraf and a companion cobas 4800 BRAF V600 Mutation Test for melanoma, both from Roche.
The approvals show that FDA and sponsors can coordinate the separate regulatory/development efforts of a drug and diagnostic through two FDA review organizations under different legal authority to accomplish targeted...