FDA Halts Studies of Combination Idelalisib due to Adverse Events

The U.S. Food and Drug Administration (FDA) has halted six clinical trials investigating idelalisib in combination with several other oncology medications and has alerted health-care professionals to the increase in adverse events, including death, in these trials.

The trials involved idelalisib in combination with other drugs for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and indolent non-Hodgkin lymphoma (NHL). The U.S. FDA said it is reviewing the findings of clinical trials and will communicate new information as necessary.

Idelalisib is FDA-approved, in combination with rituximab, for patients with relapsed CLL for whom rituximab alone is inappropriate due to other comorbidities. Idelalisib is also approved as monotherapy for patients with relapsed follicular B-cell NHL or relapsed SLL in those who have received at least two prior therapies. The U.S. FDA has not yet approved idelalisib for previously untreated CLL.

Idelalisib carries a Boxed Warning for fatal and serious liver toxicity, diarrhea, colitis, pneumonitis, and intestinal perforation.

Source: FDA news release, March 14, 2016.

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