The cancer drug tazemetostat (Tazverik) is being voluntarily withdrawn in the United States and all other markets over concerns about secondary cancers, pharmaceutical company Ipsen has announced.
The company also said it is discontinuing all active trials of the EZH2 inhibitor and any expanded access programmes, reports MedPage Today.
Based on data from single-arm trials, in 2020 tazemetostat received accelerated approvals from the FDA for patients with previously treated follicular lymphoma and an EZH2 mutation and for patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
Ipsen’s decision to pull the drug for both indications was based on emerging safety data from SYMPHONY-1, a confirmatory phase Ib/III study evaluating lenalidomide (Revlimid) plus rituximab with or without tazemetostat in follicular lymphoma.
In its statement, the company said the study’s independent data monitoring committee “advised that, based on adverse events of secondary haematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen”.
SYMPHONY-I is being conducted at 229 sites across 15 countries, including the US, Europe, and China. All participants will now only receive the standard-of-care regimen of lenalidomide-rituximab. “The study will remain open, with no further enrolment, to continue the long-term safety follow-up of all participants,” the drugmaker said.
Ipsen said it is working with the FDA on the next steps to execute the drug’s withdrawal from the American market.
Tazemetostat joins a number of recent drugs pulled from the market either for failing confirmatory trials or over safety signals – including copanlisib (Aliqopa) for follicular lymphoma, mobocertinib (Exkivity) for lung cancer, obeticholic acid (Ocaliva) for primary biliary cholangitis, and andexanet alfa (Andexxa) as an emergency reversal medication for contemporary blood thinners.
The multiple myeloma drug belantamab mafodotin (Blenrep) was pulled in 2022 after a failed trial but last year found its way back to the US market after other positive studies.
Typically, these drugs are voluntarily removed from the market by the manufacturer, but some drug companies balk. In January, the FDA requested that Amgen voluntarily withdraw avacopan (Tavneos), a treatment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis in part over safety concerns, but the company said it had no plans to pull the oral complement 5a inhibitor from the market.
The preterm birth drug injectable 17-alpha hydroxyprogesterone caproate (Makena) famously stayed on the market years after FDA advisors said the available data did not support it. FDA finally removed the drug in 2023 after a second advisory committee meeting.
MedPage Today article – Cancer Drug Pulled From Market Over Safety Concerns (Open access)
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