Mark Butler signs off on PBS listings for cancer drugs

Medicines

By Mardi Chapman

2 Jul 2026

Health Minister Mark Butler has announced a number of cancer treatments are now on the PBS for patients with lung, breast and bile duct cancer.

The pay day for lung cancer patients includes an expanded indication for alectinib (Alecensa, Roche) as adjuvant treatment of ALK-positive NSCLC following tumour resection.

The PBAC recommended alectinib for listing at its May 2025 meeting with some restrictions but subsequently updated their advice following input from ALK-positive Australia and MOGA.

“The PBAC provided additional advice on eligibility for access in the locally advanced/metastatic setting so that if alectinib is used following surgery to reduce the risk of cancer coming back, a different ALK inhibitor may be used later if needed,” the March 2026 PBAC meeting outcome said.

“After considering the additional input received from consumer and clinical groups, the PBAC advised that listing alectinib for ALK-positive NSCLC and allowing re-treatment with another ALK inhibitor if the cancer advances, would be cost-effective.”

The minister’s office said about 440 Australians were expected to benefit from this listing each year. Without the PBS subsidy, they might pay around $188,400 per course of treatment.

The indication for osimertinib (Tagrisso, AstraZeneca) has also been expanded to include the treatment of EGFR-mutated NSCLC and unresectable Stage III NSCLC following chemoradiation.

PBAC recommended the listing back in September 2025 for its use, in combination with chemotherapy, in the first-line treatment of patients with locally advanced or metastatic NSCLC with evidence of an activating epidermal growth factor receptor mutation.

It had previously rejected a submission in May 2025 due to concerns about “overestimated” benefits and “optimistic assumptions” regarding the economic model.

More than 170 Australians are expected to benefit from this listing each year. Without the PBS subsidy, they could pay more than $7,500 per pack.

Meanwhile pertuzumab (Perjeta, Roche) has been expanded for the treatment of high-risk HER2+ early breast cancer with more than 3,300 Australians each year expected to benefit from the listing. Without the PBS subsidy, they might pay up to $6,000 per pack.

Futibatinib (Lytgobi, Taiho Pharma Oceania) is also listed for the first time for the treatment of patients with previously-treated advanced or unresectable cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene alterations.

The rare cancer is often diagnosed at a later stage which can limit treatment options and explains its poor prognosis.

However, futibatinib, a highly selective, irreversible inhibitor of FGFR1–4, has been shown in a single-group, phase 2 study [link here] to deliver an objective response in 42% of patients.

A PBAC decision on futibatinib was deferred at its November 2025 meeting pending an associated MSAC approval for a MBS item for tumour testing to detect FGFR2 fusions or rearrangements in people with cholangiocarcinoma.

That has now been supported with MSAC advice for DNA and RNA next-generation sequencing “…to ensure that FGFR2 fusions and rearrangements are accurately detected.”

“Given the rapid and aggressive nature of the disease, MSAC considered that FGFR2 testing should occur at the time of cholangiocarcinoma diagnosis to prevent any delays in treatment decisions.”

About 70 Australians are expected to benefit from the listing each year. Without PBS subsidy they could pay more than $9,000 per pack.

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