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FDA Approves Cancer Drug, Diagnostic

Pfizer NSCLC drug cleared, along with Abbott test

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer received approval from the FDA for Xalkori (crizotinib) capsules, the first therapy designed to target anaplastic lymphoma kinase (ALK), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by Abbott’s molecular diagnostic test. The effectiveness of Xalkori is based on objective response rates (ORR) using a targeted approach in the registration trials. ORR of 50% and 61% were observed in patients with advanced ALK-positive NSCLC.

Pfizer worked closely with the FDA and partnered with Abbott’s Molecular business for the clinical studies to help ensure the simultaneous review and approval of Xalkori along with the diagnostic test.

Abbott received approval from the FDA for the diagnostic test Vysis ALK Break Apart FISH Probe Kit, to detect the ALK gene in NSCLC to be used as a companion diagnostic for Pfizer’s Xalkori.

“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,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business.

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