Zydelig idelalisib regulatory update

FDA approved an NDA from Gilead for Zydelig idelalisib for 3 blood cancers while EMA’s CHMP backed approval of the company’s MAA for the product for 2 blood cancers. FDA granted full approval to Zydelig in combination with rituximab to treat relapsed chronic lymphocytic leukemia (CLL), for which the compound has breakthrough therapy designation. The agency granted accelerated approval to the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta as monotherapy to treat relapsed follicular B cell non-Hodgkin’s lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) in patients who have received >=2 prior systemic therapies. The accelerated approvals are based on the single-arm Phase II Study 101-09, in which Zydelig led to an overall response rate (ORR) of 54% in 72 FL patients and 58% in 26 SLL patients.

Zydelig’s U.S. label includes a boxed warning on the risk of fatal and serious toxicities, including liver toxicity, diarrhea, colon and lung inflammation and intestinal perforation. The drug was also approved with a REMS that includes a communication plan. Gilead said it plans to launch the drug in the U.S. “as soon as possible,” with a wholesale acquisition cost of $7,200 for a 1-month supply. According to Zydelig’s label, in clinical trials the median duration of exposure to Zydelig was 5 months in CLL patients and 6.1 months in indolent non-Hodgkin’s lymphoma patients. ...