Hutchmed China Ltd - Hong Kong-based biopharmaceutical firm - The new drug application for Tazverik has been granted conditional approval by the National Medical Products Administration in China for the treatment of adult patients with relapsed or refractory follicular lymphoma with the EZH2 gene mutation who have received at least two prior systemic therapies. Approval was based on positive results from a phase II bridging study in China, and clinical studies conducted by Epizyme Inc, a subsidiary of Paris-based pharmaceutical firm Ipsen SA.
Chief Medical Officer Michael Shi comments: "We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering. It also marks our first approval in hematological malignancies, unveiling a new chapter for Hutchmed as we extend our footprint into this disease area. As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases."
Bridging study lead investigator Junning Cao adds: "This approval represents a significant advancement in the management of this challenging disease. The majority of FL patients experience multiple relapses over their lifetime, posing substantial treatment difficulties and often leading to poor outcomes. Tazverik has demonstrated promising efficacy in patients harboring EZH2 mutation in clinical trials. We are eager to provide this transformational epigenetic therapy to patients in China who have long sought new effective treatment options."
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By Aidan Lane, Alliance News reporter
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