Gilead Halts Zydelig Trials Following Patient Deaths
Clinical Trial Troubles Spark Federal Review
While it is still unclear how many clinical trial patients were negatively impacted by treatment with Zydelig, regulators have acknowledged that many of the reported side effects and deaths were the result of infections.
In response to the adverse event reports, the U.S. Food and Drug Administration (FDA) announced Monday that it would be reviewing the findings of the Zydelig trials and would communicate any new information to healthcare providers and the medical community.
Similarly, the European Medicines Agency (EMA) announced their own independent review Friday, stating that their findings could potentially impact the drug’s current approval status. European regulators also advised doctors to take extra precautions by monitoring any patients currently taking Zydelig for infections.
Halted Trials Used Unapproved Drug Combinations and Patient Groups
According to the FDA, Zydelig is already approved for the treatment of patients diagnosed with non-Hodgkin lymphoma and chronic lymphocytic Leukemia (CLL). However, filings submitted to the National Institutes of Health revealed that Gilead was testing the drug in unapproved drug combinations and on patients not covered by Zydelig’s current label.
Gilead’s attempt to expand the approved uses of Zydelig may do more harm than good for the company as the drug already bears a black-box warning label highlighting several potentially fatal side effects, including:
- Fatal liver toxicity
- Fatal inflammation of the colon
- Fatal inflammation of the lungs
- Fatal intestinal perforation
Other side effects of Zydelig include:
- Severe cutaneous reactions
- Decrease white blood cell counts
- Fetal toxicity
- Abdominal pains