Lung cancer

Lorlatinib available earlier in NSCLC with PBS listing extension


The PBS listing for lorlatinib (Lorviqua, Pfizer) has been expanded to include first-line treatment for locally advanced (stage IIIB) or metastatic (stage IV) ALK-positive non-small cell lung cancer.

The third generation ALK tyrosine kinase inhibitor was first listed on the PBS in 2020 for patients with metastatic ALK-positive NSCLC following disease progression on an ALK inhibitor other than crizotinib.

The latest PBAC decision to approve the line-agnostic listing of lorlatinib was made at its December 2021 meeting, after previously deferring a decision from July 2021 on the basis that “there was not an urgent clinical need to list in the first line setting” given the presence of an alternative therapy.

The PBAC noted in its Public Summary Document [link here] that its positive recommendation for lorlatinib was made on a cost-minimisation basis versus alectinib.

It also said lorlatinib “is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over alternative therapies”.

Evidence for lorlatinib has come from the CROWN trial [link here], and previously reported in the limbic, which initially found a PFS benefit with lorlatinib compared to crizotinib.

Pfizer has released three-year follow-up data earlier this year which again confirmed the PFS benefit [link here].

The targeted therapy has a role in about 3-5% of advanced NSCLC patients who have a rearrangement in the ALK gene.

“We are delighted that this PBS-listing will now provide Australian patients who have this rare form of lung cancer with equitable and affordable access to this targeted medicine as their first-line treatment”, said John Dimopoulos, Oncology Commercial Lead, Pfizer Australia & New Zealand.

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