More treatment options for non-small cell lung cancer
More treatment options for non-small cell lung cancer
11 Dec 2015The FDA approved another inhibitor of anaplastic lymphoma kinase (ALK) for treatment of non-small cell lung cancer (NSCLC), the agency announced. Alectinib (Alecensa) is indicated for advanced, metastatic, ALK-positive NSCLC in patients unresponsive to or intolerant of another ALK inhibitor, crizotinib (Xalkori).
A new treatment option for NSCLC patients
"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," 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 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."
Two single-arm trials supported alectinib's approval, the agency said. In particular, according to the clinical results:
- In one, 38% of patients had partial shrinkage of NSCLC tumors lasting a mean of 7.5 months.
- In the other, 44% had partial responses with a mean duration of 11.2 months.
- Among patients with brain metastases in the two trials, 61% showed complete or partial elimination of those tumors with mean duration of 9.1 months.
What about the adverse events?
Fatigue, constipation, edema, and myalgia were the most common adverse effects seen in the studies, the FDA said. More serious but less common effects included liver abnormalities, severe lung inflammation, bradycardia, and muscle toxicity.
The agency also noted that patients may be more sensitive to sunburn while taking alectinib. Alectinib is marketed by Roche's Genentech unit.
Source: MedPage Today