Faced with risky side effects, this treatment is immediately withdrawn from the market and clinical trials, according to a press release published by the manufacturing laboratory.
Its benefit/risk ratio is now unfavorable. The French laboratory Ipsen announces the withdrawal “immediate” of one of his medications including “the risks could exceed the potential benefits for patients”. The latest data on the effects of the drug highlighted “a more unfavorable safety profile, compared to that previously observed during the clinical evaluation” according to the manufacturer’s press release.
To make this decision, the pharmaceutical laboratory Ipsen based itself on the results of a clinical trial carried out in 15 countries, including the United States, several countries of the European Union and China. It focused on patients suffering from follicular lymphoma, a cancer which affects, for example, several thousand new people per year in France. The objective was to see if adding the famous drug to a treatment already used against this disease could improve the health of patients, helping to better control the cancer or prolong the duration of remission. In the end, the drug worked for some, but the trial did not show that it actually improved outcomes compared to the treatment already available. Worse, it exposed patients to additional side effects. Among these effects: the occurrence of “secondary hematological malignancies” that is, new blood cancers that appeared during treatment.
This medication is Tazverik® (tazemetostat). Ipsen is withdrawing it from the market for the treatment of cancer and is also withdrawing it from the current clinical trial. This will still continue so that researchers can monitor the safety of the participants in the long term, but there will be no new inclusion. Ipsen is also halting all active clinical trials of Tazverik® and expanded access programs. What exactly is Tazverik®? It is a targeted cancer medicine that works by blocking an enzyme involved in the growth of certain tumor cells and is used to treat certain rare cancers such as follicular lymphoma or epithelioid sarcoma.
It was not marketed in France or in Europe but was administered to certain patients with rare or difficult-to-treat cancers, as part of clinical trials or early access devices. The Medicines Agency (ANSM) specifies on its website that, since August 31, 2023, the medicine is no longer made available within the framework of compassionate access (access allowing seriously ill patients to obtain a medicine which is not yet authorized or not yet available in the country, when they no longer have any other effective treatment). Since this date, only patients already treated can continue the medication via renewal requests, if the doctor considers that the benefit remains sufficient.
Tazverik®, on the other hand, has been marketed in the United States by Ipsen since 2020 for certain follicular lymphomas and for advanced or metastatic epithelioid sarcoma. In light of the latest results, the drug should therefore no longer be used across the Atlantic.
