Gilead Sciences Inc (NASDAQ:GILD) recently notified the FDA of its decision to voluntarily withdraw the use of Zydelig for two types of blood cancer, including follicular lymphoma (FL) and small lymphocytic leukemia (SLL).
- In 2014, the FDA granted accelerated approval to treat relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukemia, along with relapsed Chronic Lymphocytic Leukemia (CLL).
- Related content: Benzinga's Full FDA Calendar.
- The accelerated approval was based on a Phase 2 study in indolent non-Hodgkin lymphoma, showing that 54% of those with FL and 58% of those with SLL had an objective response.
- The continued approval for these indications was contingent upon providing evidence supporting the confirmation of clinical benefit in FL and SLL.
- The company noted, as the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge.
- Gilead said Zydelig would continue to be sold in the U.S. market for treating CLL. It will be available to treat CLL and FL in the European Union, the U.K., Canada, Australia, New Zealand, and Switzerland.
- Price Action: GILD shares closed lower by 0.15% at $71.77 on Friday.
