Ipsen stock price drops 3% as Tazverik drug is withdrawn due to blood cancer risk

Investing.com - Ipsen SA (EPA:IPN) withdrew its anti-cancer drug Tazverik from all markets on Monday after a clinical trial monitoring committee found the treatment may cause secondary blood cancers, causing the stock to fall 3%.

The French pharmaceutical company immediately withdrew the use of tazemetostat in its two approved indications, including relapsed or refractory follicular lymphoma and epithelioid sarcoma.

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An independent Data Monitoring Committee overseeing the Phase Ib/III SYMPHONY-1 trial determined that adverse events related to secondary hematologic malignancies suggest the risks may outweigh the benefits. The trial is testing Tazverik in combination with lenalidomide and rituximab.

Ipsen’s R&D director Christelle Huguet said, “New data from this confirmatory study show that its safety profile is not as favorable as observed in earlier clinical assessments.”

The U.S. Food and Drug Administration (FDA) granted accelerated approval for Tazverik for these two indications in 2020, but continued approval depends on confirmatory trial data, which SYMPHONY-1 was designed to provide. Ipsen said it is working with the FDA on the withdrawal process.

The company is stopping all Tazverik treatment for patients in the SYMPHONY-1 trial, which involves 229 research centers across 15 countries. Participants will only receive lenalidomide and rituximab. The trial will continue to allow long-term safety follow-up but will no longer recruit new patients.

All other active Tazverik trials and expanded use programs have been terminated. Ipsen stated that this withdrawal will not affect its financial guidance.

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