TGA approval for leukaemia drug

2 minute read

The cancer drug, venetoclax, used for advanced chronic lymphocytic leukaemia, has been approved by the TGA


A cancer drug for advanced chronic lymphocytic leukaemia (CLL) has been approved by the TGA.

Venetoclax (Venclexta) is an oral treatment for patients with relapsed or refractory CLL with 17p deletion or without other suitable treatment options.

Around 1,300 Australians are diagnosed with CLL each year. The 17p deletion affects around one in 10 patients with CLL.

The drug was developed by US pharmaceutical companies AbbVie and Genentech to target a particular protein, BCL-2, which prolongs the survival of cancer cells.

Clinical trials conducted in Australia and the US showed promising responses in almost 80% of participants, while 20% went into complete remission.

The drug is contraindicated for patients taking CYP3A inhibitors at initiation and during the dose titration phase.

The drug should also not be prescribed to patients with hypersensitivity to venetoclax. Due to rapid tumour reduction, venetoclax carries a risk of tumour lysis syndrome in the initial five-week dose titration phase. The drug may also affect male fertility.

Side effects include neutropenia, diarrhoea, nausea, upper respiratory tract infection, low platelet count and fatigue.

The approval of venetoclax in Australia, as well as in the US and the EU last year, is the culmination of a 30-year hunt for a mechanism to block the BCL-2 protein.

Further clinical trials are currently underway to investigate the use of venetoclax in combination with approved drugs to treat other blood cancers.

Preclinical testing has also suggested that lung and prostate cancers might respond to venetoclax.

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