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News & Trends - Pharmaceuticals

Oncologists and patient group hail landmark PBS listing of first targeted therapy for rare lung cancer

Health Industry Hub | February 3, 2025 |

Australians living with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene mutation now have access to a novel targeted therapy, with Eli Lilly’s oral kinase inhibitor, Retevmo (selpercatinib), listed on the Pharmaceutical Benefits Scheme (PBS). The medicine was approved by the Therapeutic Goods Administration (TGA) back in July 2023.

Professor Tom John, Medical Oncologist at Peter MacCallum Cancer Centre, said “Retevmo is the first and only approved and reimbursed targeted treatment for these patients, offering a much-needed alternative to chemotherapy, which is what most patients would have only had access to. This advancement represents a significant leap forward in our ability to provide targeted, effective care and brings new hope to patients and their families.”

While the listing marks a significant milestone, oncologists are being urged to implement and increase RET biomarker testing in lung cancer immediately at diagnosis, which is also reimbursed by government. This can help ensure patients get the right treatment for their cancer and may improve outcomes.

In the LIBRETTO-431 Phase 3 trial, patients with RET fusion-positive NSCLC were randomly assigned to receive Retevmo or Alimta (pemetrexed) and the investigator’s choice of platinum-based chemotherapy (cisplatin or carboplatin) with or without MSD’s PD-1 inhibitor Keytruda (pembrolizumab).

Findings presented at the European Society for Medical Oncology (ESMO) 2023 Congress highlighted Retevmo’s superiority over the Keytruda-chemotherapy combination. The study showed that Retevmo reduced the risk of progression or death by 53.5%, more than doubling median progression-free survival to 24.8 months, compared to 11.2 months for patients receiving standard treatment (p<0.001).

“This announcement is a positive step towards affordable and equitable access to a potentially life-saving lung cancer treatment for those patients in real need,” said Christine Cockburn, CEO of Rare Cancers Australia.

“People with rare and less common cancers, including rare lung cancers, simply do not have the same access to treatments and support as those with more common cancers. And they pay for that inequity with their lives. I hope to be able to support more announcements like today’s, so that everyone, regardless of their cancer type, has affordable access to the treatments they need and the best possible chance to live beyond cancer.”

More than 15,000 Australians were diagnosed with lung cancer in 2024. While it is the fifth most commonly diagnosed cancer, it carries one of the poorest survival rates, with over half of patients dying within a year of diagnosis.

With the PBS listing of Retevmo, more than 250 Australians with this rare form of lung cancer are expected to benefit from improved access to targeted treatment. The therapy can be used first-line or offered to patients who have previously received other cancer treatments.

Gabrielle Reppen, Associate Vice President, Corporate Affairs & Market Access at Lilly ANZ, said “We’re delighted for patients with this rare lung cancer that Retevmo is now widely available – following approval we have been working closely with Government to ensure subsidised access.

“This news demonstrates our commitment to delivering life-changing medicines to people living with cancer, and we urge patients to ask their doctors about biomarker testing.”

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