AstraZeneca’s fixed-duration oral combo PBS listed in newly diagnosed blood cancer

Australians living with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) now have first-line reimbursed access to AstraZeneca’s oral Calquence (acalabrutinib) in combination with AbbVie’s Venclexta (venetoclax) through the Pharmaceutical Benefits Scheme (PBS).

The expanded PBS listing provides patients with access to a fixed-duration treatment option, offering an alternative to the long-term use of Bruton tyrosine kinase (BTK) inhibitors that are typically taken until disease progression. While patients newly diagnosed with CLL commonly remain on a BTK inhibitor such as BeOne’s Brukinsa indefinitely, treatment with Calquence combination is limited to 14 months, potentially reducing treatment burden and improving quality of life.

Dr Wojt Janowski, clinical haematologist at Calvary Mater Newcastle Hospital, said “The more reimbursed treatment options that people with CLL and SLL have access to, the better. Given that many people living with CLL and SLL are older and may spend years managing their condition, having an additional first-line treatment option for their unique circumstance is appreciated.”

Blood cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related death after lung cancer. Around 20,000 Australians were diagnosed with blood cancer in 2025, while more than 135,000 people are currently living with the disease.

Clinical evidence supporting the PBS listing comes from the Phase III AMPLIFY trial, which demonstrated improved outcomes for patients receiving Calquence plus venetoclax compared with standard-of-care chemotherapy. At three years, 77% of patients treated with the combination remained progression free, compared with 67% of patients receiving standard chemotherapy. Median progression-free survival (PFS) was not reached in the Calquence arm, versus 47.6 months for chemoimmunotherapy. The combination therapy also reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy (p=0.0038).

Sharon Winton, CEO of Lymphoma Australia, stated “People with CLL and SLL live with a chronic condition and may require treatment for years and even decades4, which makes it important for them to have reimbursed access to as many treatment options as possible. Our hope is that the inclusion of targeted therapies, like Calquence, on the PBS will help our patient community in the management of their disease and provide some reassurance that affordable treatment options are available to them when they need it.”

AstraZeneca Australia and New Zealand’s Country President, Dr Marie Guillet, said the listing represents an important expansion of access for patients facing complex and long-term treatment journeys.

“Blood cancers are complex and challenging to treat, and many patients experience long treatment journeys and limited options,” said Dr Guillet. “AstraZeneca welcomes the Australian Government’s investment in this expanded listing, which will provide hundreds of additional patients per year with PBS access to Calquence as their first treatment option.”

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