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FDA reports increase of adverse events with Zydelig, six trials stopped
The FDA alerted health care professionals about an increase in adverse events, including deaths, in clinical trials with idelalisib in combination with other cancer medicines.
The drug’s manufacture, Gilead Sciences, has stopped six clinical trials of idelalisib (Zydelig) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL) and indolent non-Hodgkin’s lymphoma.
The agency is reviewing the findings of the clinical trials and will communicate new information as necessary, according to a press release from the FDA.
The FDA previously approved idelalisib in combination with rituximab (Rituxan, Genentech) for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to other comorbidities. Idelalisib also is approved for patients with relapsed follicular B-cell non-Hodgkin’s lymphoma or relapsed SLL who received at least two prior systemic therapies.
The FDA has not approved idelalisib for previously untreated CLL.
The agency urged health care professionals and patients to report any adverse events involving idelalisib.