Roche has secured marketing authorization from the China National Drug Administration (CNDA) for its Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive and advanced non-small cell lung cancer (NSCLC).
The approval follows the priority review of Alecensa in China, just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals, respectively.
Alecensa is a selective, CNS active and oral medicine developed at Chugai Kamakura Research Laboratories. It is being developed for people with NSCLC whose tumours are identified as ALK-positive.
At present, Alecensa secured approval in more than 57 countries as an initial (first-line) treatment for ALK-positive and metastatic NSCLC.
The approval was based on primary analyses from the global phase III Alex study, which evaluated the Roche’s drug against crizotinib in the first-line treatment of people with ALK-positive metastatic (advanced) NSCLC and pharmacokinetics results in Asian patients from the phase III Alesia study.
The regulator also considered the investigation of Alecensa compared to crizotinib in the first-line setting, and two phase II studies evaluating Alecensa in patients who have progressed on or are intolerant to crizotinib.
Alex is a randomised, multicentre, open-label and phase III study designed to evaluate the efficacy and safety of Alecensa against crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the Ventana ALK (D5F3) CDx assay.
Alesia is a randomised, multicentre and open-label phase III study designed to assess the efficacy and safety of Alecensa against crizotinib, and the pharmacokinetics of Alecensa in Asian patients with treatment-naive ALK-positive advanced NSCLC.
Roche global product development head and chief medical officer Sandra Horning said: “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.
“It also represents a significant regulatory shift, with the approval received under unprecedented timelines. We are proud to be at the forefront of healthcare innovation in China by helping to bring Alecensa to patients as quickly as possible.”