EMA advice on use of Zydelig (idelalisib) to include an antibiotic.- Gilead Sciences

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) from Gilead Sciences, to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).

The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystisjirovecii pneumonia). 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 not be started in patients with a generalised infection. It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation). These are provisional recommendations which the PRAC has issued, as a precaution, to protect patients while the medicine is being reviewed.