15 March 2016 | Regulatory | By BioSpectrum Bureau
Gilead's cancer drug under FDA scrutiny
Zydelig is currently approved by the FDA for the treatment of relapsed chronic lymphocytic leukemia
Singapore: US Food and Drug Administration has raised alarm for Gilead Science's cancer medicine Zydelig (idelalisib) due to incoming reports of an increased rate of adverse events, including deaths.
According to FDA, Gilead Sciences has decided to halt six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas.
Zydelig is currently approved by the FDA for the treatment of relapsed chronic lymphocytic leukemia, in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities; relapsed follicular B-cell non-Hodgkin lymphoma in patients who have received at least two prior systemic therapies; relapsed small lymphocytic lymphoma in patients who have received at least two prior systemic therapies.