HUTCHMED initiated a full market recall of the oncology drug Tazverik across Greater China on Monday, following a global withdrawal by partner Ipsen due to emerging safety data linking the therapy to secondary blood cancers.
The company announced the immediate suspension of all sales, shipments, and clinical trials for Tazverik (tazemetostat) in mainland China, Hong Kong, and Macau.
The move follows a directive from Ipsen, the drug's global marketing authorization holder, to pull the EZH2 inhibitor from all markets worldwide after an independent monitoring committee identified a localized risk of secondary hematologic malignancies in a confirmatory study.
The safety signal emerged from the Phase 1b/3 SYMPHONY-1 trial, which was evaluating tazemetostat in combination with lenalidomide and rituximab for follicular lymphoma.
Data from the trial suggested that the risk of developing secondary blood cancers may outweigh the potential clinical benefits for patients within that specific treatment regimen.
While the withdrawal marks a sudden end to the drug's commercial life, HUTCHMED indicated the impact on its broader oncology portfolio would be minimal.