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Ventana ALK IHC Test Gets FDA Approval as CDx for Pfizer's Xalkori

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved an immunohistochemistry companion diagnostic developed by Roche subsidiary Ventana Medical Systems, the firm announced today.

The ALK (D5F3) CDx Assay will be another FDA-approved tool that healthcare providers can use to identify lung cancer patients who express ALK and are likely to respond well to Pfizer's Xalkori (crizotinib). The drug was approved in 2011 for ALK-positive non-small cell lung cancer patients alongside Abbott Molecular's Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test.

FISH-based assays, which can identify specific genetic translocations, can be costly and require pathologist expertise to perform testing and interpret the results. IHC, however, is more broadly available at different healthcare institutions, and in Ventana's own analysis has shown high concordance with FISH testing.

"Traditional FISH ALK testing methods have required patients to wait weeks before receiving their ALK mutation status," Dan Zabrowski, president of Roche Tissue Diagnostics, said in a statement. "With an approved ALK IHC test, physicians and their ALK-positive patients now have the option to learn their ALK status and start an ALK-targeted therapy within days."

Ventana garnered a CE-IVD mark for its ALK IHC assay in Europe in 2012, and Chinese regulators approved it in 2013. The approval from the Chinese Food and Drug Administration was based on a retrospective study that involved 1,100 Chinese subjects, and the Ventana assay demonstrated 99 percent concordance with Abbott's Vysis ALK Break Apart FISH test.

Ventana and Pfizer collaborated on the development of the IHC test, and retrospectively assessed the diagnostic's ability to identify NSCLC patients in clinical trials who would benefit from Xalkori. The FDA used this data to approve Ventana's test. The ALK (D5F3) CDx Assay has a Class III (high-risk) classification from the FDA, and runs on Ventana BenchMark IHC instruments.

After Xalkori became available on the market, Novartis received approval for Zykadia (ceritinib) for ALK-positive non-small cell lung cancer patients who are no longer responding to Xalkori. Roche subsidiary Genentech is also developing the next-generation ALK inhibitor alectinib. Ventana, which submitted the application for this test with the FDA earlier this year, has said its ALK diagnostic is also being studied alongside Zykadia and aletinib.