Gilead Sciences has voluntarily withdrawn the US indications for Zydelig® (idelalisib) for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL).
In 2014, Zydelig received accelerated approval for these indications based on data from a phase 2 study (ClinicalTrials.gov Identifier: NCT01282424), which showed an objective response rate of 54% in patients with FL and 58% in patients with SLL, as assessed by an independent review committee. Continued approval required further verification and description of clinical benefit in a confirmatory trial.
The decision to withdraw the indications was made after the Company determined that “as the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge.”
Patients who are currently receiving Zydelig treatment for relapsed FL or SLL in the US should discuss their treatment options with their health care provider.
Zydelig will remain on the market as it continues to be indicated 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 comorbidities.
Gilead statement on Zydelig® US indication for follicular lymphoma and small lymphocytic leukemia. News release. Gilead Sciences, Inc. Accessed January 19, 2022. https://www.gilead.com/news-and-press/company-statements/gilead-statement-on-zydelig-us-indication-for-follicular-lymphoma-and-small-lymphocytic-leukemia