US FDA approves Gilead's Zydelig for three types of blood cancers

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US biotech major Gilead Sciences (Nasdaq: GILD) to treat patients with three types of blood cancers. Gilead’s share rose 1.1% to $90.34 by close of trading Wednesday, but edged back to $89.90 in after-hours trading.

Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA, and the third drug with this designation approved to treat CLL.

The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who have received at least two prior systemic therapies.