The Food and Drug Administration has approved the use of Alecensa (alectinib) for the treatment of patients with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with Xalkori (crizotinib). Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.
"This 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 FDA's Office of Hematology and Oncology Products, said in a news 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."
Alecensa had previously received priority review designation for this approval.
Safety and Efficacy
The drug's Alecensa were established in two single-arm clinical trials of patients with ALK-positive NSCLC whose disease was no longer being controlled with treatment with Xalkori. Patients received Alecensa twice daily. In a Phase II study with 87 patients, 38 percent of the patients experienced a partial shrinkage of their NSCLC tumors, an effect that lasted an average of 7.5 months.
In another Phase I/II study with 138 patients, 44 percent had a partial shrinkage of their tumors, which lasted an average of 11.2 months. The trials also examined Alecensa's effect on brain metastases. Sixty-one percent of participants in the two trials who had measurable brain metastases had a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.
The most common side effects for Alecensa are fatigue, constipation, edema, and myalgia. Serious side effects included liver problems, severe or life-threatening inflammation of the lungs, very slow heart beats, and severe muscle problems. Treatment with Alecensa may cause sunburn when patients are exposed to sunlight, the FDA noted.
Accelerated Approval
Alecensa, marketed by Genentech, was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. For this indication for Alecensa, the tumor response to treatment, along with the duration of response, provided this evidence, the FDA noted in a news release. Under the accelerated approval requirements, a confirmatory study is required to verify and describe the clinical benefit of Alecensa.
Alecensa has also received Breakthrough Therapy and Orphan Drug designations for this indication.
Clinical Quick Facts: Alecensa
Drug: Alecensa (alectinib)
Approved Indication: Treatment of patients with advanced ALK-positive non-small cell lung cancer whose disease has worsened after, or who could not tolerate treatment with Xalkori (crizotinib)
Serious Side Effects: Inflammation of the lungs, very slow heart beats, and severe muscle problems
Common Side Effects: Fatigue, constipation, edema, and myalgia