China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer

发布时间： 2018-09-30 阅读：1059次

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Roche today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa? (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval follows priority review of Alecensa 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.

“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,” said Sandra Horning, MD, 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. We are proud to be at the forefront of healthcare innovation in China by helping to bring Alecensa to patients as quickly as possible.”

In updated analyses of the phase III ALEX study presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, the primary endpoint of investigator assessed progression-free survival (PFS) was more than tripled in people who received Alecensa 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

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.

【from  roche】