IDELALISIB, marketed in Australia as Zydelig, should no longer be used in combination with rituximab in specific situations, according to a safety review conducted by the Therapeutic Goods Administration.
Idelalisib is an antineoplastic agent which is approved to treat some rare kinds of blood cancer by affecting the growth of cancerous lymphocytes.
The TGA review was undertaken after advice from the product's sponsor, Gilead Sciences, of a potential increased risk of serious adverse events in patients receiving the medicine in combination with other cancer drugs to treat chronic lymphocytic leukaemia (CLL) and relapsed indolent non-Hodgkin's lymphoma (iNHL).
Affected patients received the medicine as part of now-ceased phase 3 clinical trials.
The TGA found the results, which related to currently unapproved uses for Zyde3lig, were also relevant to some of the previously approved uses for the medicine, with resulting changes to indications for idelalisib and additional information relating to serious infections, including a boxed warning, now added to the product information for the medication.
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