FDA Approves Zydelig, Expands Imbruvica
On July 23, the FDA approved Zydelig (idelalisib) for the treatment of patients with relapsed CLL, in combination with rituximab, for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is manufactured by Gilead.
The CLL approval was based on a 220-patient study of idelalisib+rituximab vs placebo+rituximab. The study demonstrated improved progression free survival in the idelalisib+rituximab arm.
Idelalisib was also approved for
for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior therapies.
The FDA is requiring a Boxed Warning to indicate serious instances of hepatotoxicity, severe diarrhea or colitis, pneumonitis, and intestinal perforation. The most common adverse reactions (incidence greater than or equal to 20%) are diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash. The most common lab abnormalities (incidence greater than or equal to 30%) are neutropenia, hypertriglyceridemia, hyperglycemia, ALT elevations, and AST elevations.
A week after the FDA approved idelalisib, the agency expanded the use for Imbruvica (ibrutinib) to include patients with chromosome 17p deletion. The approval was partially based on data from 127 participants who had CLL with 17p deletion. Patients were treated with either ibrutinib or ofatumumab. Those treated with ibrutinib experienced a 75 percent reduction in risk of disease progression or death.
Both idelalisib and ibrutinib will likely be approved in Europe soon. The scientific committee of the European Medicines Agency (EMA) adopted a positive opinion on both agents on July 25. The next step is for the European Commission to review the applications.