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FDA Clears Abbott's Companion Dx for Pfizer's NSCLC Drug

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Abbott's companion diagnostic kit to detect rearrangements of the anaplastic lymphoma kinase gene in non-small cell lung cancer.

Abbott's Vysis ALK Break Apart FISH Probe is for use with Pfizer's Xalkori (crizotinib) ALK-inhibitor, whose approval was also announced by FDA on Friday after the close of the market.

The Vysis ALK Fish uses fluorescence in situ hybridization technology to detect rearrangements on the ALK gene on the 2p23 chromosome, Abbott said, adding that it provides clinicians "a standardized, clinically validated" method to identify those patients who may benefit the most from Pfizer's drug.

The test is designed to identify the 3 percent to 5 percent of all NSCLC patients who would be candidates for Xalkori, and the approval of the test and the drug is expected to change how patients with NSCLC are diagnosed and treated, Abbott said.

Globally, more than 1.6 million new cases of lung malignancies are diagnosed annually with about 85 percent of lung cancer patients having the non-small cell type, the company said. Patients diagnosed with NSCLC often have advanced disease and a low survival rate.

"The Abbott-Pfizer collaboration marks a breakthrough in the advancement of personalized medicine – and companion diagnostics specifically – that will help a subset of lung cancer patients get treatment tailored to their unique genetic profile," Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement.

Pfizer said that the approval of its drug with Abbott's test is the first time that one of its oncology drugs "or any lung cancer medication was developed and approved in parallel with a diagnostic test."

Earilier this month Qiagen announced a deal with Pfizer to develop a companion diagnostic test based on Qiagen's proprietary KRAS assay technology also targeting NSCLC. The test is for use with Pfizer's dacomitinib, an oral inhibitor of HER-1 (EGFR), HER-2, and HER-4 tyrosine kinases.

The Vysis ALK Fish test will be available to clinicians and pathologists through Abbott Molecular.

This is the second FDA clearance for a companion diagnostic product in the past two weeks following the agency's approval of Roche's cobas 4800 BRAF V600 Mutation Test for use with Zelboraf (vemurafenib), a therapy co-developed by Roche and Daiichi Sankyo for treating patients with late-stage unresectable melanoma.

Xalkori was approved based on two multicenter single-arm studies with a total of 255 patients with late-stage ALK-positive NSCLC, and the Vysis ALK Fish test was approved based on data from one of the studies, FDA said.

FDA reviewed the drug under its priority review program, which provides an expedited six-month review of drugs that "may offer major advances in treatment or that provide a treatment when no adequate therapy exists," it said in a statement. Xalkori was approved under the agency's accelerated approval program, which allows FDA to approve drugs based on clinical data indicating the drug has an effect "on an endpoint that is reasonably likely to predict a clinical benefit to patients."

The Abbott companion diagnostic was approved ahead of FDA's review goal date of Sept. 28, while Xalkori was approved ahead of the agency's Sept. 30 goal date.

"The trend in oncology research continues towards targeted therapies," Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in a statement. "This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases."

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