The China National Drug Administration have granted rapid approval of Roche’s (Basel, Switzerland) Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
The approval comes just 8 months after the EMA approval and 9 months after the FDA approval.
“Today’s approval marks a new era for ALK-positive lung cancer patients in China, who now have a treatment option that offers a meaningful, sustained benefit compared with the previous standard of care,” explained Sandra Horning Roche’s Chief Medical Officer and Head of Global Product Development. “It also represents a significant regulatory shift, with the approval received under unprecedented timelines.”
Unlike in western countries, lung cancer incidence rates have continued to rise in China, with NSCLC being the most common form of the disease.
The approval is based on analyses from several studies including the pivotal global Phase III ALEX study (assessing Alecensa versus crizotinib in the first-line treatment of people with ALK-positive metastatic-advanced NSCLC), the Phase III ALESIA study (pharmacokinetics results in Asian patients also investigating Alecensa compared to crizotinib in the first-line setting) and two Phase II studies assessing Alecensa in patients who have progressed on or are intolerant to crizotinib.
In updated analyses of the Phase III ALEX study, the primary endpoint of investigator assessed progression-free survival was more than tripled in individuals who received Alecensa compared with those who received crizotinib. Additionally, the ALESIA study met its primary endpoint and demonstrated that Alecensa as an initial (first-line) treatment significantly reduced the risk of disease worsening or death (PFS) compared to crizotinib in Asian patients with ALK-positive NSCLC, will be submitted to the CNDA to complete a post-approval agreement.
Alecensa is now approved in over 57 countries around the world as an initial (first-line) treatment for ALK-positive advanced NSCLC, including the US, Europe and Japan.