China National Drug Administration Grants Approval to Alectinib for ALK-positive NSCLC

Lung cancer incidence rates in China have continued to rise, with NSCLC the most common form of the disease

On 20 August 2018, Roche announced that the China National Drug Administration (CNDA) has granted marketing authorisation for alectinib (Alecensa®) as a monotherapy for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval follows priority review of alectinib in China and has been granted just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals, respectively. 

The approval is based on primary analyses from the pivotal global phase III ALEX study, assessing alectinib versus crizotinib in the first-line treatment of patients with ALK-positive metastatic (advanced) NSCLC, the pharmacokinetics results in Asian patients from the phase III ALESIA study, also investigating alectinib compared to crizotinib in the first-line setting, and two phase II studies assessing alectinib in patients who have progressed on or are intolerant to crizotinib. 

Primary data from the ALEX study were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and were published in the New England Journal of Medicine. In updated analyses of the ALEX study presented at the 2018 ASCO Annual Meeting, the primary endpoint of investigator assessed progression-free survival (PFS) was more than tripled in patients who received alectinib compared to those who received crizotinib (34.8 months [95% CI: 17.7 months-NE) versus 10.9 months [95% CI 9.1-12.9 months]) as assessed by the investigator. 

Further supporting the use of alectinib in this setting, the phase III ALESIA study, which met its primary endpoint and showed that alectinib as a 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. This is the third phase III study to show that alectinib was superior as an initial treatment compared to crizotinib in this type of lung cancer. Full results from the ALESIA study will be presented at an upcoming medical meeting. 

Unlike in western countries, lung cancer incidence rates have continued to rise in China, and the disease is the most commonly diagnosed cancer type and the leading cause of cancer-related deaths. NSCLC is the most common form of lung cancer, with ALK-positive NSCLC, a distinct form, commonly affecting younger people (median age 52), and those with a light or non-smoking history. Approximately 5% of NSCLC cancer cases are ALK-positive and ALK-positive status is almost always found in patients with lung adenocarcinoma.

Alectinib is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories. It is now approved in over 57 countries around the world as an initial treatment for ALK-positive advanced NSCLC. It was approved by the FDA and the EMA in November and December 2017, respectively.