European regulator to probe Zydelig safety
The European Medicines Agency has begun a review of Gilead’s blood cancer drug Zydelig (idelalisib) after clinical trials of combinations with other drugs raised safety concerns.
The regulator said late on Friday that the review has been started because of an increased rate of serious adverse events including deaths, mostly due to infections, which was seen in three clinical trials investigating Zydelig in combination with other drugs.
Zydelig is authorised in the EU for chronic lymphocytic leukaemia and non-Hodgkin lymphoma. The EMA said the Zydelig combination trials that raised the safety issues were in chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma.
At the request of the European Commission, the EMA will review data from these studies to assess whether findings affect authorised use of Zydelig and patients starting or on treatment should be carefully monitored for signs of infections.
It is also considering whether measures are necessary while the review is ongoing and will keep doctors and patients informed.
The EMA’s Pharmacovigilance Risk Assessment Committee will carry out the review and recommendations will be forwarded to the Committee for Medicinal Products for Human Use, which will adopt a final position.
This will by passed to the European Commission, which will publish a legally binding decision applicable to all EU member states.
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