All patients given the cancer drug idelalisib (marketed as Zydelig) should be prescribed antibiotics during treatment and for two to six months after treatment has ended to prevent pneumonia, according to a new Europe-wide proposal.
Following a safety review of the drug, the European Medicines Agency’s Pharmacovigilence Risk Assessment Committee (PRAC) says patients taking idelalisib should be monitored for infection and have regular tests for white blood cell counts, because a low reading indicates increased infection risk. It also says idelalisib should also never be started in patients with a generalised infection.
The drug is indicated for the treatment of two blood cancers — chronic lymphocytic leukaemia (CLL) and follicular lymphoma.
The safety review was prompted by the results of three clinical trials, which found a higher rate of serious adverse events related to infections, such as pneumonia, in patients who received idelalisib compared with placebo.
The PRAC agreed that the benefits of the drug outweighed the risks but decided new recommendations governing the risk of Pneumocystis jirovecii pneumonia and the prescribing of antibiotics were needed.
The review also supports lifting the temporary ban on giving idelalisib to patients with previously untreated CLL whose cancer cells have 17p deletion or TP53 mutation cells, a ban that was introduced ahead of the review.
The PRAC recommendations now go to the EMA’s Committee for Medicinal Products for Human Use for final adoption.