EMA Determines Benefits of Zydelig Outweigh Risks

July 12, 2016
Pharmaceutical Technology Editors

The agency completes its risk assessment of the blood cancer treatments.

The European Medicines Agency (EMA) has completed its review of the blood cancer treatment Zydelig (idelalisib) and determined that the benefits outweigh the risks. The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed the treatment following a high rate of serious adverse events associated with the drug. PRAC did determine that there is a risk of serious infections with use of the medication, including Pneumocystis jirovecii pneumonia.

EMA states that, “the risk of serious infection is considered relevant to the authorized use and the PRAC recommends that all patients treated with Zydelig should be given antibiotics to prevent Pneumocystis jirovecii pneumonia during treatment and for up to 2 to 6 months after treatment has stopped. Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection. Zydelig should also not be started in patients with a generalized infection.”

Zydelig (idelalisib) is used, in combination with rituximab, for the treatment of chronic lymphocytic leukaemia (CLL) in patients who have received previous treatment. It is also used to treat “previously untreated patients who have certain genetic mutations in their cancer cells (17p deletion or TP53 mutation) that make them unsuitable for treatment with a combination of chemotherapy medicines and immunotherapy (treatments that stimulate the immune system to kill cancer cells)," according to EMA. Zydelig (idelalisib) is also authorized in the European Union for the treatment of a type of non-Hodgkin’s lymphoma called follicular lymphoma. 

Source: EMA