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FDA Approves Alectinib for ALK-Positive NSCLC

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has granted an accelerated approval to alectinib (Alecensa) as a treatment for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) following progression on crizotinib (Xalkori). The approval was based on objective response rates (ORR) seen in two phase II clinical trials.

In the first study, labeled NP28761, the ORR with alectinib was 38% by independent review and 46% by investigator assessment, with a duration of response of 7.5 months. For the second trial, known as NP28673, the ORR was 44% by independent review, 48% by investigator assessment, and the duration of response was 11.2 months.

“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.” Click here to read the full article at

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