BMS secures PBS listing for leukaemia treatment

Pharma News: Bristol Myers Squibb Australia (BMS) has announced a milestone for Australians battling acute myeloid leukaemia (AML). Starting September 1, 2023, patients will gain access to Onureg* (azacitidine) as part of the Pharmaceutical Benefits Scheme (PBS).

Onureg, approved by the Therapeutic Goods Administration (TGA) in 2022, stands as the oral counterpart of BMS’ long-standing Vidaza (azacitidine) which was acquired through the merger with Celgene. It offers a distinct advantage with its oral convenience and accessibility compared to traditional injectable treatments for AML.

The approval process is anchored in the compelling results from the pivotal Phase 3 QUAZAR AML-001 study. The study’s findings revealed a statistically significant and clinically substantial advancement in overall survival (OS)—the primary objective of the research. A remarkable increase of nearly 10 months in median OS was observed among patients treated with Onureg, when compared to those who received a placebo. The numbers spoke for themselves: a median OS of over two years (24.7 months) for Onureg recipients, in stark contrast to the 14.8 months observed in the placebo group (p=0.0009).

Professor Andrew Wei, Lead Investigator at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, stated “The globally conducted phase 3 QUAZAR AML-001 study demonstrated that Onureg therapy improved overall survival in adults with AML in first complete remission after intensive chemotherapy and, notably, has the potential to do this in a convenient manner, given its once daily oral formulation.”

A significant increase of nearly 10 months in median overall survival (OS) was observed among patients treated with Onureg when compared to those who received a placebo – 24.7 months and 14.8 months respectively (p=0.0009).

“The PBS listing of Onureg is the culmination of over a decade of research and more than five preclinical and clinical trials in Australia. We are grateful to the patients, families and caregivers who participated in and supported these trials, and who ultimately made today’s announcement possible,” declared Leah Goodman, Managing Director of Bristol Myers Squibb Australia and New Zealand.

A staggering 73% of adult leukaemia cases in Australia are attributed to AML, equating to 900 patients each year. Despite the strides made through induction chemotherapy, where 40-60% of patients achieve complete remission, the harsh reality is that 50% relapse within a year. The prognosis of relapsed AML patients is generally poor but also depends on the timing of relapse (early vs late) and the possibility of allogeneic haematopoietic stem cell transplantation (HSCT).

*Onureg is indicated for the continued treatment of adult patients with AML who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

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