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European Regulators Grant Conditional Approval for Pfizer's Xalkori; Abbott Begins Marketing ALK CDx

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The European Commission has granted conditional marketing authorization to Pfizer's Xalkori (crizotinib), a personalized treatment for non-small cell lung cancer.

The drug is indicated as a treatment for advanced NSCLC patients who have been previously treated and whose tumors have rearrangements in the ALK gene. The US Food and Drug Administration approved Xalkori in August 2011, with a companion test developed by Abbott Molecular that gauges whether patients have ALK-positive tumors (PGx Reporter 9/7/2011).

Concurrent with the EC approval, Abbott announced this week that it will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit, allowing it to be sold in the EU as a companion diagnostic for the drug.

The conditional marketing authorization from the EC means that Pfizer still has certain studies to complete before gaining full regulatory approval in EU countries. "Now that Xalkori has been granted a conditional marketing authorization, Pfizer will be required to submit data to the European Medicines Agency from the recently completed PROFILE 1007 study," Pfizer said in a statement.

The Phase III randomized study compared the efficacy and safety of Xalkori against pemetrexed or docetaxel in 347 ALK-mutation positive NSCLC patients who had been previously treated with chemotherapy (PGx Reporter 10/3/2012). In the study, patients receiving Xalkori experienced progression-free survival of 7.7 months compared to 3 months for patients treated with standard chemotherapy. Around 65 percent of Xalkori-treated patients responded to the drug while 20 percent responded to treatment on the chemo arm.

The overall survival data from this study is not yet mature. Patients on the chemotherapy arm were switched to receive Xalkori. Certain adverse reactions were more frequent for study participants receiving Xalkori, but patients on this drug also reported improved quality of life.

"Following review of the 1007 results by the EMA’s Committee for Medicinal Products for Human Use, the European Commission will consider converting the conditional marketing authorization to a normal marketing authorization," Pfizer said. The committee in July recommended that regulatory authorities grant conditional marketing for Xalkori in previously treated advanced NSCLC patients with ALK-positive tumors.

Abbott, meantime, said it will expand the CE-IVD product labeling for its ALK test so that it can be sold in the EU as a companion diagnostic for Xalkori. According to the diagnostics developer, the ALK test has been available in Europe since September last year with CE-IVD certification. However, the assay has been used for research purposes.

"Laboratories throughout Europe are familiar with and experienced in using the Vysis ALK FISH test so they will be able to start testing lung cancer patients immediately to help doctors decide if Xalkori is the right treatment option for them," Kristina Rodnikova, head of Abbott’s molecular diagnostics business in Europe, said in a statement.

Abbott highlighted that its test is the only diagnostic used in the clinical trials that led to FDA approval of Xalkori.

Between 3 percent and 5 percent of NSCLC patients harbor ALK rearrangements that make them likely to respond to Xalkori.

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