EMA reviews cancer medicine Zydelig
Review follows concerns over serious adverse events in ongoing clinical trials.
The European Medicines Agency (EMA) has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), which is authorised in the EU to treat two types of rare blood cancers called chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).
The review has been started because an increased rate of serious adverse events including deaths, mostly due to infections, was seen in three clinical trials investigating the medicine in combination with other cancer medicines. The clinical trials involved patients with chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukaemia investigated combinations of medicines that are currently not approved and the studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indications.
Investigators of all clinical trials involving Zydelig are currently being informed of the actions to be taken in relation to the conduct of ongoing studies.
EMA will now review the data from these studies to assess whether the findings have any consequences for the authorised uses of Zydelig. In the meantime, patients starting or on treatment with Zydelig should be carefully monitored for signs of infections. If Zydelig is well tolerated, treatment should not be stopped.
EMA is considering whether any other immediate measures are necessary while the review is ongoing. The Agency will communicate further and keep doctors and patients informed as appropriate.
The review of Zydelig has been initiated at the request of the European Commission, under Article 20 of Directive 2001/83/EC.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...