J&J and AbbVie oral combo PBS listed in blood cancer

Pharma News: From October 1, an oral, fixed-duration treatment combining Johnson & Johnson Innovative Medicine’s Imbruvica (ibrutinib) and AbbVie’s venetoclax will become available through the Pharmaceutical Benefits Scheme (PBS) for newly diagnosed patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

This PBS listing marks a significant shift in drug delivery, offering a shorter, more targeted therapy. The oral combination treatment involves taking Imbruvica tablets daily for three months, followed by 12 months of both Imbruvica and venetoclax. After completing the 15-month course, patients stop the therapy entirely.

Professor Con Tam, Head of Lymphoma Services at Alfred Health, described this fixed-duration approach as a breakthrough in managing these blood and bone marrow cancers.

“The traditional response to this and most forms of cancer is to treat until the cancer progresses. This often means that people receive treatment for many years, which can be costly, increase the likelihood of side effects, and become mentally gruelling,” he explained.

He added, “Now, we can tell patients at the outset that this treatment will be taken at home and last for 15 months. It’s an exciting new era, and we thank the Federal Health Minister for making this combination therapy available on the PBS.”

CLL and SLL are both forms of non-Hodgkin’s lymphoma, with CLL specifically affecting the bone marrow and blood, disrupting the production of healthy white blood cells that protect against infection. Together, nearly 2,000 cases of these cancers are diagnosed annually in Australia.

The latest findings from the Phase 2 CAPTIVATE study, which was showcased at the 2024 American Society of Clinical Oncology (ASCO) meeting, revealed that at a median follow-up of 61.2 months, 67% of patients treated with the fixed-duration combination therapy were progression-free and alive at 5-years. Notably, median PFS was not reached even after up to 5.5 years of follow-up, indicating sustained disease control. The 5-year overall survival (OS) rate was 96% for all treated patients.

Professor Tam, who played a key role in the landmark Imbruvica-venetoclax clinical trial, highlighted the synergy between the two therapies.

“CLL usually progresses slowly, so for patients, it’s akin to living with a long-term illness. Most patients remain on treatments of one form or another for many years,” he said. “Our aim is to optimise treatment in a way that allows people to live life as closely as possible to normal.”

Lymphoma Australia CEO Sharon Winton praised the government’s decision to fund this new treatment option, noting its significant impact on patients.

“The long-term treatment of CLL/SLL can take a significant emotional, physical, and financial toll,” she said. “Affordable access to a new all-oral fixed-duration therapy is amazing news for the lymphoma and leukaemia communities.”

Joana De Castro, Managing Director of Johnson & Johnson Innovative Medicine ANZ, echoed this sentiment, calling the PBS listing “an important milestone for CLL/SLL patients.”

“Since the Imbruvica-venetoclax treatment combination was registered by the TGA, we have worked tirelessly through reimbursement processes to secure access for Australians living with CLL and SLL,” she said.

“Australian patients deserve timely and equitable access to innovative medicines, and we remain committed to playing our part in delivering this in cooperation with the Federal Government.”

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