A new anti-cancer medication has been approved by the TGA for treatment of the most common type of leukaemia in Australia
Venclexta (venetoclax) is a once-daily oral B-cell lymphoma-2 inhibitor that has been approved by the TGA this month, for use by patients with harder-to-treat forms of chronic lymphocytic leukaemia.
The decision is a “major milestone” according to the developers AbbVie in collaboration with the Walter and Eliza Hall Institute.
Around 1,300 people diagnosed with chronic lymphocytic leukaemia each year, making it the most common form of leukaemia in the country.
“The TGA’s approval of Venclexta marks a major milestone for AbbVie, and more importantly for the patients diagnosed with these difficult to treat forms of chronic lymphocytic leukaemia,” says Kirsten O’Doherty, the General Manager of AbbVie ANZ.
“We are working with the Australian Government to make Venclexta available through PBS funding as early as possible.”
According to AbbVie, the safety and efficacy of the new drug were established in two clinical trials, while the results of a randomised controlled Phase 3 study are awaited.
Clinical trials of venetoclax have delivered outstanding results for patients, says the Walter and Eliza Institute.
One study saw remission in patients with an advanced form of leukaemia, for whom conventional treatment options had been exhausted.
In this trial, 79% of those involved had promising responses to the breakthrough therapy – including 20% who went into a complete remission.
Professor Andrew Roberts, a clinical haematologist at The Royal Melbourne Hospital and head of clinical translation at the Walter and Eliza Hall Institute, said most trial patients responded positively to the therapy, showing substantial reductions in the number of leukaemia cells in their body.
“Many patients have maintained this response more than a year after their treatment began, and some patients remain in remission more than four years on,” Professor Roberts said.
The most common adverse reactions found in the trials were neutropenia/decreased neutrophil count, diarrhoea, nausea, anaemia, upper respiratory tract infection, fatigue, hyperphosphatemia, vomiting, and constipation.