Coagulation

TGA to review blood cancer drug amid safety concerns

Wednesday, 16 Mar 2016


Clinicians should avoid prescribing the antineoplastic agent idelalisib (Zydelig) as a first line treatment says the TGA following safety concerns with the drug.

The advice comes after makers of the drug Gilead Sciences put a halt to several phase 3 trials on Monday after reports of serious adverse events among study participants including infections leading to death.

Patients were receiving the medicine in combination with other cancer drugs to treat chronic lymphocytic leukaemia and relapsed indolent non-Hodgkin’s lymphoma.

The CLL study investigated non-approved combinations of medicines whereas the studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indications.

Gilead Sciences has notified the clinical trial investigators who are participating in idelalisib clinical trials involving Australian patients.

In a statement issued this morning the TGA said it was currently reviewing information it had received and was seeking further details from Gilead Sciences to determine what action to take.

“In the meantime, Gilead Sciences is advising prescribers to avoid using idelalisib as a first line treatment,” the statement said.

Patients starting or continuing treatment should be carefully monitored for signs of infection, however, if the treatment was well tolerated it should not be stopped, it said.

The FDA and the EMA are also reviewing the cancer medicine.

Indications and product information for the use of Zyledig in Australia can be found here.

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