EMA Recommends New Safety Measures for Idelalisib

Measures include close monitoring and use of antibiotics to prevent pneumonia

European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine idelalisib (Zydelig) to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat chronic lymphocytic leukaemia (CLL) and follicular lymphoma.

The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent Pneumocystis jirovecii 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.

The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo. The adverse events included deaths related to infections such as pneumonia. The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma. However, these studies did not use the medicine in the same way as currently authorised.

Healthcare professionals will be informed in writing about the precautionary measures to be taken. Once the review is concluded, EMA will communicate further and provide guidance to patients and healthcare professionals.

The above safety measures have been recommended upon the PRAC meeting in June 2016.