Roche's ALK Inhibitor Alectinib Granted New Indication in China for Adjuvant Treatment of Early-Stage ALK-Positive NSCLC

On July 5, according to the NMPA website, Roche's ALK inhibitorAlectinib Hydrochloride Capsules Approved for New Indication in China.

From:NMPA Official Website

Previously, it was approved for the first time in China in August 2018, as a single agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who are positive for anaplastic lymphoma kinase (ALK).

Alectinib was first approved for marketing in the United States in 2015.In April this year, Roche announced that a new indication for Alectinib (Alecensa) had been approved for marketing by the DFA.Adjuvant treatment after complete tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive NSCLC。AlectinibBecoming the first and currently the only ALK inhibitor approved for the treatment of early-stage ALK-positive NSCLC patients whose tumors have been surgically removed.

Previously announced Phase III clinicalALINA StudyPositive results.

The study enrolled a total of 257 subjects, with disease-free survival (DFS) as the primary endpoint. The results showed that, in patients with completely resected stage IB-IIIA ALK-positive NSCLC, Alecensa reduced the risk of disease recurrence or death by 76% compared to the platinum-based chemotherapy group (HR=0.24, 95% CI: 0.13-0.43, p<0.0001).

In addition, in an exploratory analysis, an improvement in central nervous system (CNS) disease-free survival (DFS) was also observed (HR=0.22, 95% CI: 0.08-0.58). In terms of safety, the safety and tolerability profile of Alectinib was consistent with previous studies, and no new unexpected safety issues were observed.

AlectinibTaking the lead in the first-line ALK-positive NSCLC indication in major markets, with continuous growth in 2023, achieving sales of approximately $1.652 billion, ranking TOP12 in Roche's pharmaceutical product sales.The approval of adjuvant therapies will further expand the market space.