Gilead Sciences has immediately halted the continuation of six clinical trials. The US Food and Drug Administration (FDA) says that the use of Idelaslisib (Zydelig) has led to serious adverse events and several deaths in clinical trial participants.
Idelaslisib is used, in combination with other medications, to treat relapsed chronic lymphocytic leukemia (CLL). It is also used in combination with riguximab, for relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma.
A warning has been issued to clinicians not to prescribe this drug to patients that have untreated CLL. The clinical trials included patients with CLL and indolent non-Hodgkin lymphoma.
The FDA is now reviewing the findings of these six trials. The FDA also says that healthcare professionals are unaware that the drug is not approved for use in patients with untreated CLL.
The number of deaths associated with this series of clinical trials is not readily available as an investigation is ongoing.
If you participated in any of the six clinical trials involving Idelaslisib or Gilead Sciences, Inc. and have suffered a severe adverse medical event or have lost a family member during these trials, contact the attorneys at Harman Law LLC. You or your family may be entitled to financial compensatio. The attorneys at Harman Law offer every client and their families a free, no cost and no obligation consultation to discuss your potential case. Contact us today at 1-888-55-HARMAN or 404-554-0777 to schedule your consultation.