Venetoclax will be listed on the PBS from 1 December for the treatment of patients with newly diagnosed acute myeloid leukaemia (AML), ineligible for standard intensive remission induction chemotherapy, given in combination with azacytidine.
The expended listing is expected to provide access to the drug for around 340 patients a year with AML who would otherwise have to pay may more than $88,800 per course of treatment.
The PBS listing was welcomed by the Leukaemia Foundation, who noted that intensive chemotherapy followed by stem cell transplant is the current standard of care for the treatment of AML. However this is often unsuitable for a large proportion of people diagnosed with AML due to age or other comorbidities.
It said that older patients with AML currently have a poor prognosis, and the five-year survival rate for patients diagnosed with AML remains approximately 29%.
The Foundation also noted that as an oral therapy venetoclax would offer convenience in treatment as it can be taken as an outpatient, avoiding visits to day care for treatment.
Venetoclax received a recommendation for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at is July meeting, after the committee concluded that venetoclax in combination with azacitidine provides, for some patients, a significant improvement in efficacy over low-intensity azacitidine or low-dose cytarabine.
In a sponsor hearing the PBAC meeting heard from clinicians who said that azacitidine was the current treatment of choice for this patient population in other jurisdictions, although it is not currently available on the PBS.
The meeting heard that the use of venetoclax was supported by results of the VIALE-A randomised trial that compared venetoclax with azacitidine versus azacitidine, in which patients in the control arm were similar to patients in the Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry (ALLG NBCR) receiving low-intensity therapy.
“The clinician stated that the venetoclax arm in VIALE-A had seen earlier and more durable response results, with lower risk of infection and less dependence on blood transfusions, all contributing to an improved overall survival,” the Public Summary Document stated.
Professor Andrew Wei a haematologist at The Alfred Hospital and Monash University, Melbourne, who led the VIALE trials of venetoclax said he was very pleased to have this new drug available to older patients with AML.
“In combination with low dose chemotherapy, two-thirds of patients will now have their bone marrow cleared of leukaemia within just a few weeks.
This new discovery and this new drug builds on three decades of research, which includes seminal discoveries by research scientists here in Australia, at the Walter and Eliza Hall Institute of Medical Research, and by clinicians and physicians around the world who have conducted the clinical trials,” he added.