Alecensa a New First-Line Treatment for NSCLC with ALK Mutation

December 2017, Vol 7, No 12 - FDA Approvals, News & Updates


On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori).

“ALK-positive lung cancer is often found in younger people, who tend to have more advanced disease at the time of diagnosis, and comes with a unique set of challenges,” said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation. “We applaud advancements in care, like the approval of Alecensa, which provides a new initial treatment option for people with this type of lung cancer.”

The approval of alectinib as first-line treatment for metastatic NSCLC with ALK mutation was based on data from the open-label, randomized, active-controlled, multicenter ALEX clinical trial, in which patients were randomized in a 1:1 ratio to oral alectinib 600 mg twice daily or to oral crizotinib 250 mg twice daily.

The primary end point was investigator-assessed progression-free survival (PFS). Other efficacy measures were PFS as determined by independent review committee, time to central nervous system (CNS) progression, objective response rate, duration of response, and overall survival.

Alectinib significantly reduced the risk for disease progression or progression to the brain or CNS compared with crizotinib by 84% (hazard ratio, 0.16; 95% confidence interval, 0.10-0.28; P <.0001). This was based on a time to CNS progression analysis in which there was a lower risk for progression in the CNS as the first site of disease progression for patients who received alectinib (12%) versus patients who received crizotinib (45%).

The most common (≥20%) adverse reactions reported with alectinib were fatigue, constipation, edema, myalgia, and anemia.