FDA Approves Alectinib for ALK-Positive Non-Small Cell Lung Cancer
Posted: Thu Nov 17, 2016 2:04 pm
The Food and Drug Administration (FDA) approved alectinib (Alecensa®) on December 11, 2015, for some patients with metastatic non-small cell lung cancer (NSCLC) with mutations in the ALK gene.
The agency granted an accelerated approval for alectinib for patients whose cancer is no longer responding to the ALK-targeted agent crizotinib (Xalkori®) or who are unable to tolerate further treatment with crizotinib because of side effects.
In both trials, treatment with alectinib also had an effect on tumors that had spread to the brain. Collectively, 61 percent of patients in the trials who had brain metastases had partial or complete reductions in the tumors that lasted a median of 9.1 months."
https://www.cancer.gov/news-events/canc ... inib-nsclc