Zydelig - referral
Current status
Referral
Human
Patients should be monitored for infection and given antibiotics during and after treatment
On 21 July 2016 CHMP (EMA's Committee for Medicinal Products for Human Use) confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects. However, following a review it updated recommendations to minimise the risk of serious infections in patients treated with the medicine.
All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped. Patients receiving Zydelig should also be monitored for signs of infection and have regular blood tests to measure the level of white blood cells. Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted. Zydelig should also not be started in patients with any generalised infection.
In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP concluded that treatment with Zydelig can again be started in these patients provided alternative treatments are not suitable and provided that the measures to prevent infection are followed.
The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines. In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field. Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use. The CHMP confirmed the recommendations from the PRAC review, and its opinion was sent to the European Commission which issued a final legally binding decision.
117p deletion or TP53 mutation, see EMA recommends new safety measures for Zydelig (18/03/2016)
A letter will be sent to healthcare professionals, advising them of these changes.
2GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL; GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL; GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL.
Zydelig is a cancer medicine containing the active substance idelalisib. In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
See more information on the approved uses of Zydelig.
The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion on 21 July 2016. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 15 September 2016.
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
Note that older documents may have different titles.