Expediting Companion Diagnostic Development Through Collaboration

August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

Such simultaneous approval of drug and companion diagnostic is the very approach laid out in the guidance. Yet achieving this synchronicity is a major challenge, particularly because few, if any, companies are equipped to handle development of a drug and diagnostic on their own. In the case of Xalkori, it took close collaboration between Pfizer, Abbott, and LabCorp. Pfizer and Abbott, which created the companion diagnostic, jointly met with the FDA beginning in July 2009. Just over two years later, the drug and companion diagnostic were approved. Abbott and Pfizer submitted and gained accelerated approval based on Phase II data. Phase III and other post-market studies are on-going. LabCorp provided validation and global testing to support Abbott’s regulatory submission for the assay and then, when it was approved, immediately made the test commercially available nationwide. LabCorp played a similar role in the approval and roll out of Roche’s Zelboraf, the other targeted drug and companion diagnostic approved in August 2011.