Good news for lung cancer patients! Ripotinib capsules approved for marketing in China
Reporters recently learned from Shanghai-based Zai Lab that Ripotinib capsules have been approved by the China National Medical Products Administration for the treatment of adult patients with ROS1 gene-positive locally advanced or metastatic non-small cell lung cancer. This innovative drug is a tyrosine kinase inhibitor and was included in priority review by the State Food and Drug Administration in May last year. Now, it will be used in clinical treatment, bringing good news to many lung cancer patients.
Statistics show that more than 800,000 people are newly diagnosed with lung cancer in my country every year, of which non-small cell lung cancer accounts for about 85%. About 70% of non-small cell lung cancer is already locally advanced or metastatic when initially diagnosed. Among domestic patients with advanced non-small cell lung cancer, 2% to 3% have ROS1 rearrangements. Brain metastases are very common in such patients. However, the intracranial activity of tyrosine kinase inhibitors previously approved for marketing may be Not ideal.
The National Medical Products Administration approved the marketing of Ripotinib capsules.
Can repotinib capsules achieve high clinical response rates and durable responses, including intracranial response? In January this year, data from a registration phase 1/2 clinical study was published in the top international medical journal "The New England Journal of Medicine". This is a global multi-center, single-arm, open-label, multi-cohort Phase 1/2 clinical study, named TRIDENT-1, designed to evaluate repotinib in patients with advanced solid tumors, including non-small cell lung cancer. safety, tolerability, pharmacokinetics and antitumor activity.
In this study, 519 patients received one or more doses of repotinib, with 103 patients participating in the Phase 1 clinical study and 416 patients participating in the Phase 2 clinical study. The primary endpoints were the maximum tolerated dose and/or recommended phase 2 dose as assessed by an independent blinded center based on one criterion, and confirmed objective response rate. Secondary endpoints of this clinical study include: duration of response, progression-free survival and safety.
Clinical study results show that Ripotinib exhibits a high response rate and durable response, and covers patients with brain metastases. Treatment with this new drug is generally well tolerated, has a manageable safety profile, and can be used long-term.
Zai Lab participated in the TRIDENT-1 study and completed the administration of the first patient in China in May 2021. According to reports, the efficacy and safety data of the Chinese subgroup are consistent with those of the global population, showing a robust response rate and durable clinical activity in patients with ROS1-positive non-small cell lung cancer, and the overall safety is controllable.
It was based on this clinical study that Ripotinib was approved for marketing in China. In June last year, China’s National Medical Products Administration accepted the new drug marketing application and included it in priority review. In November last year, Ripotinib was approved by the U.S. Food and Drug Administration for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.
