FDA Approves Genentech Medicine for First-Line Treatment of Specific Type of Lung Cancer
November 6th, 2017
On November 6th, the US Food and Drug Administration (FDA) approved Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
News in brief
- Approval is based on results from the Phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to crizotinib.
- In the Phase III study, Alecensa also showed a significant reduction in the risk for cancer to spread or grow in the brain compared to crizotinib.
- In addition to today’s approval, the FDA also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.
Supporting Information
"Our goal is to develop medicines that have the potential to significantly improve upon the standard of care. In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”