BioCentury
ARTICLE | Clinical News

Zydelig idelalisib regulatory update

July 18, 2016 7:00 AM UTC

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of Gilead’s Zydelig idelalisib, concluding that the benefits of the blood cancer drug outweigh the risks in patients with chronic lymphocytic leukemia (CLL) or follicular lymphoma. EMA started the review after high rates of infection-related serious adverse events, including deaths, were observed in 3 Zydelig trials (see BioCentury, March 21).

The PRAC confirmed that Zydelig has a risk of serious infections, including Pneumocystis jirovecii pneumonia, and recommended that all patients receiving Zydelig be given antibiotics to prevent P. jirovecii infection during treatment and for up to 2-6 months after ending treatment. The committee also recommended that patients be monitored for infection and low white blood cell counts and against starting Zydelig in patients with generalized infection. ...