Eisai Co., Ltd. has announced plans to discontinue the administration and sales of its anticancer agent Tazverik (tazemetostat hydrobromide) in Japan. This decision follows the voluntary withdrawal of the product in the United States and other countries due to safety concerns.
The company has been reviewing safety data from clinical trials and postmarketing reports, which revealed multiple cases of secondary hematologic malignancies associated with both combination and monotherapy treatments using tazemetostat. After a comprehensive evaluation, Eisai concluded that the risk of these malignancies necessitates discontinuing the drug in Japan, even under approved conditions of use.
Eisai is currently communicating with medical institutions in Japan to ensure the immediate discontinuation of Tazverik for patients currently receiving it and to prevent the initiation of new treatments. The company emphasized its commitment to providing timely and appropriate information to healthcare professionals to minimize confusion or disruption.
The SYMPHONY-1 trial, a phase 1b/3 study, is evaluating the efficacy of adding tazemetostat to the standard second-line treatment of rituximab plus lenalidomide (R2 therapy) in patients with relapsed or refractory follicular lymphoma. This trial is being conducted under Ipsen's leadership as a confirmatory trial for the accelerated approval of Tazverik in the United States and China, involving 229 sites across 15 countries. However, no sites in Japan are participating.
Tazemetostat, a first-in-class oral small molecule inhibitor targeting EZH2, was developed under a collaboration between Eisai and Epizyme, Inc., an Ipsen company. Eisai holds exclusive development and commercialization rights for the agent in Japan.
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