Chemo-free leukaemia treatment approved by FDA

Tuesday, 25 June, 2019

Chemo-free leukaemia treatment approved by FDA

An international trial into the treatment of chronic lymphocytic leukaemia (CLL) has been so successful that the US FDA approved the treatment for patients with the disease prior to the trial data being presented.

With contributions from centres in Australia, New Zealand, the UK, Russia, Italy, the US and Bulgaria, the Phase 3 trial involved 432 patients with CLL, the most common form of leukaemia. There are more than 1000 cases of CLL in Australia every year, with an average patient age of 70 years.

The trial tested a new chemotherapy-free combination of BCL2 inhibitor venetoclax and monoclonal antibody obinutuzumab in older patients. After 24 months, 88% had their disease progression halted with almost undetectable levels of disease in their bone marrow and blood; only 64% of patients had their disease progression halted with the standard combination. The cocktail of drugs only needs to be given for 12 months, which is shorter than other emerging treatments.

“While younger patients (ie, under 65) diagnosed with CLL can have aggressive chemotherapy, the average, older CLL patient tolerates strong chemotherapy poorly due to co-existing conditions,” said study co-author Professor Stephen Opat, from Australia’s own Monash University.

“The high remission rate, excellent tolerability and fixed treatment time of only 12 months means that treatment of CLL is likely to change globally following the dissemination of the trial results.”

The results of the trial have since been published in The New England Journal of Medicine and presented at the latest meeting of the American Society of Clinical Oncology.

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