The U.S. regulator grants traditional approval for Gilead Sciences' (GILD +0.4%) Zydelig (idelalisib) as a treatment for chronic lymphocytic leukemia (CLL) that has relapsed. Zydelig is to used with Rituxan (rituximab) (OTCQX:RHHBY +0.3%) (BIIB +11.6%) in cases where Rituxan alone is appropriate therapy. In a Phase 3 clinical trial, patients treated with Zydelig + Rituxan demonstrated mean progression-free survival of 10.7 months compared to 5.5 months for the Rituxan + placebo cohort.
The agency grants accelerated approval (BTD designation) for Zydelig as a treatment for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). It is to be used to treat patients who have received at least two prior systemic therapies.