FDA Approves Genentech’s Lung Cancer Drug Alecensa

The FDA Dec. 11 approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who couldn’t tolerate treatment with, another therapy called Xalkori (crizotinib).

An ALK (anaplastic lymphoma kinase) gene mutation can occur in several different types of cancer cells, including lung cancer cells, the Food and Drug Administration said. ALK gene mutations are present in about 5 percent of patients with NSCLC.

Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading, the agency said. Alecensa ...