The U.S. Food and Drug Administration has granted alectinib (ALECENSA) accelerated approval for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who do not respond or have disease progression after treatment with crizotinib (Xalkori).1

The accelerated approval comes after the release of results from 2 multicenter, single arm clinical trials. In both trials patients with ALK-positive metastatic NSCLC with disease progression or intolerance to crizotinib received a 600 mg dose of alectinib twice a day and objective response rate was the major efficacy outcome.

In the first study 38% of patients demonstrated a partial NSCLC tumor shrinkage, which lasted a mean of 7.5 months. In the second trial 44% of patients had a partial response, with a mean duration of 11.2 months. In a pooled analysis of data from both trials researchers found that 61% of patients experienced complete or partial central nervous system tumor shrinkage, lasting a median of 9.1 months.

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In the 253 patients who received the twice daily dose of alectinib, the most common grade 1 to 2 side effects were fatigue, constipation, edema, and myalgia and side effects.

Dyspnea was the most common grade 3 to 4 side effect. Nineteen percent of the enrolled patients reported serious adverse events, which included dyspnea, pulmonary embolism, and elevations in bilirubin. Elevations in bilirubin, CPK, ALT, AST, and vomiting were the adverse events that most commonly led to dose reductions or breaks in therapy.

“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,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”


  1. FDA approves new oral therapy to treat ALK-positive lung cancer [news release]. Silver Spring, MD: U.S. Food and Drug Administration; December 11, 2015. Accessed December 11, 2015.