Hutchmed (China) (HCM) said Friday that China's National Medical Products Administration granted conditional approval for the new drug application for Tazverik as a treatment for adult patients with relapsed or refractory follicular lymphoma.
The company said results of a phase 2 trial supported the conditional approval, with Tazverik demonstrating "promising efficacy." Hutchmed said the ongoing SYMPHONY-1 study is intended to be the confirmatory trial to validate Tazverik's clinical benefits.
Hutchmed is in charge of Tazverik's development and commercialization in China, Hong Kong, Macau and Taiwan, while Epizyme is the marketing authorization holder in China, according to the statement.
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