Ipsen is voluntarily pulling the blood cancer drug Tazverik from the market, announcing that a potential link to secondary malignancies has led it to conclude the medicine’s risks may outweigh its potential benefits.
The decision revealed Monday was based on emerging data from a trial meant to confirm Tazverik’s benefits in follcular lymphoma. Tazverik is currently approved to treat that malignancy as well as another cancer called epithelioid sarcoma. But a group of independent trial monitors unearthed certain unspecified “secondary hematologic malignancies” in the study, which tested the medication alongside the drugs lenalidomide and rituximab. Ipsen said it is discontinuing all ongoing clinical studies of Tazverik and withdrawing it, effective immediately.
Tazverik was initially developed by the biotechnology company Epizyme and, in 2020, cleared via an accelerated approval for epithelioid sarcoma. Epizyme had high hopes for Tazverik, having reacquired full commercial rights to the therapy from Eisai five years before the FDA nod. In June of that year, the drug gained approval in another indication: follicular lymphoma.
The drug failed to generate strong sales for Epizyme, though, contributing to growing financial struggles for the company and a depressed stock price. Epizyme eventually sold itself to Ipsen in 2022 in a bargain deal struck while confirmatory trials of Tazverik were ongoing.
Ipsen has also had a hard time accelerating Tazverik’s launch. At one point, Ipsen forecasted 500 million euros in peak sales. But it dialed back those projections in the fourth quarter of 2025.
In a note to clients Monday, Jefferies analyst Lucy Codrington wrote that the drug’s “lackluster sales” have put some scrutiny on management’s “business development credibility.” Removing the drug from market would have a “minor impact” on the firm’s valuation, she wrote. Codrington’s team expected 255 million euros in peak Tazverik sales.
Ipsen didn’t disclose how many cases of secondary hematologic malignancies were recorded in the trials. It’s initiated steps to stop treatment with Tazverik in the ongoing study and ensure that all trial participants receive the standard of care only. The study will remain open to continue monitoring treatment recipients for long-term safety.
The withdrawal is not expected to impact financial guidance, Ipsen said.