Hutchmed (China) Limited has announced a significant development in the regulatory pathway of tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in China. The company disclosed that the New Drug Application (NDA) for tazemetostat has been accepted for review by the China National Medical Products Administration (NMPA), which has also granted it Priority Review status.
Tazemetostat, a pioneering methyltransferase inhibitor targeting EZH2 developed by Epizyme, Inc., an Ipsen company, has already received approvals in various regions including the United States and Japan. In the U.S., it is indicated for certain patients with relapsed or refractory FL and advanced epithelioid sarcoma (ES). Hutchmed has entered into a strategic collaboration for the research, development, manufacturing, and commercialization of tazemetostat in China, Hong Kong, Macau, and Taiwan.
The acceptance of the China NDA follows comprehensive clinical evaluations, including a multicenter, open-label Phase II bridging study conducted within China, supplemented by studies conducted by Epizyme outside China. This submission underscores Hutchmed’s commitment to addressing critical unmet medical needs in hematological cancers within the Chinese healthcare landscape.
Follicular lymphoma, a subtype of non-Hodgkin’s lymphoma, represents a significant portion of hematologic malignancies globally. In China alone, approximately 16,000 new cases of follicular lymphoma were estimated in 2020, highlighting the urgent need for effective treatment options.
Furthermore, Hutchmed is actively engaged in the international clinical study SYMPHONY-1, led by Ipsen, evaluating the combination of tazemetostat with rituximab and lenalidomide in patients with relapsed or refractory FL. This study aims to further establish the safety and efficacy profile of tazemetostat in this patient population.
Tazemetostat, marketed under the name Tazverik, has demonstrated notable clinical outcomes and safety profiles in its approved indications. Its ongoing clinical development and potential approval in China underscore Hutchmed’s dedication to advancing innovative therapies for cancer and immune-related disorders globally.
Hutchmed (China) Limited, recognized as a forward-thinking biopharmaceutical enterprise, remains committed to advancing the frontiers of targeted therapies and immunotherapies, aiming to redefine standards of care and improve patient outcomes across a spectrum of oncological and immunological diseases.