On March 21, Gelonghui announced that Hutchmed (China) (00013.HK) has received conditional approval for the new drug Tazverik (tazemetostat) in China, indicated for the treatment of adult patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic treatments. This approval was obtained through the China National Medical Products Administration's ("NMPA") priority review process and marks the first national regulatory approval for Tazverik in China.
This conditional approval from the NMPA is based on a multicenter, open-label Phase II bridging study conducted in China, as well as clinical studies conducted by Epizyme, Inc. ("Epizyme"), a subsidiary of Ipsen, outside of China. The primary objective of the bridging study was to assess the objective response rate (ORR) of Tazverik in treating patients with relapsed/refractory follicular lymphoma with EZH2 mutations, and secondary objectives included evaluating the duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics in patients with or without EZH2 mutations. Further details of the study can be found on clinicaltrials.gov by searching registration number NCT05467943.
Dr. Cao Junying, the principal investigator of the bridging study and a physician at Fudan University Shanghai Cancer Center, stated: "This approval brings significant treatment advances for this challenging disease. Most patients with follicular lymphoma may experience multiple relapses throughout their lives, posing great difficulties for treatment and often leading to poor outcomes. In clinical trials, Tazverik has demonstrated good efficacy in patients with EZH2 mutations. The company looks forward to delivering this groundbreaking epigenetic therapy to patients in China who have long been seeking new effective treatments."
