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FDA approves crizotinib for advanced ALK-positive NSCLC

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Pfizer announced recently that the FDA has approved crizotinib for treatment of patients with anaplastic lymphoma kinase with locally advanced or metastatic non–small cell lung cancer.

The approval is based on two multicenter, single-arm studies: PROFILE 1005 and Study 1001, a part 2 expansion cohort of a phase 1 study. Patients in both studies were treated with crizotinib (Xalkori) for more than 10 months.

In PROFILE (n=136), researchers observed an objective response rate of 50%, with one complete response and 67 partial responses. Median duration of treatment was 22 weeks, and 79% of observed objective responses occurred within the first 8 weeks of treatment. Median response duration was 42 weeks.

Objective response rate was 61% in Study 1001 (n=119), including two complete responses and 69 partial responses. Median duration of treatment was 32 weeks, and 55% of objective tumor responses occurred during the first 8 weeks of treatment. Median response duration was 48.1 weeks.

The most common adverse reactions (≥25%) in both studies were vision disorder, nausea, diarrhea, vomiting, edema and constipation. Grade-3/grade-4 adverse reactions observed in at least 4% of patients in both studies included neutropenia and increased alanine transaminase.

Pfizer worked with Abbott Molecular to develop that company’s Vysis ALK Break Apart FISH Probe Kit. The kit identifies the presence of the anaplastic lymphoma kinase (ALK) fusion gene, which in turn acts as a biomarker for patients most likely to benefit from treatment with crizotinib.

Paul Bunn, MD, professor of medicine and James Dudley chair in cancer research at the University of Colorado School of Medicine, called crizotinib a model for future drug development. The University of Colorado Cancer Center has been involved in all phases of the drug’s development and use, including creating the Vysis test and enrolling the first patients in the clinical trials.

“By truly understanding the underlying genetic drivers of NSCLC, such as ALK, we can select patients who are more likely to respond to treatment,” Bunn said in a press release. “Xalkori represents a paradigm shift in NSCLC treatment, where we’re moving away from a one-size-fits-all approach to biomarker-based treatment decisions.”

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