BRIEF—FDA priority review for Alecensa as first ALK inhibitor in lung cancer

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application and granted Priority Review for Roche subsidiary Genentech’s ALK inhibitor Alecensa (alectinib) as adjuvant treatment following surgery for early-stage lung cancer (NSCLC).

The FDA is expected to mark a decision by May 22.

If approved, Alecensa will be the first and only ALK inhibitor for early-stage ALK-positive NSCLC, a rare form of NSCLC caused by an abnormal ALK gene.

Pointing out the significance, Genentech noted that, in the Phase III ALINA study, adjuvant Alecensa reduced the risk of disease recurrence or death by 76% in early-stage ALK-positive NSCLC, compared with chemotherapy.

Today, nearly half of early-stage ALK-positive NSCLC patients experience disease recurrence following surgery despite chemotherapy.

The application is being reviewed under FDA's Real-Time Oncology Review pilot program to ensure safe and effective treatments are available to patients as early as possible.