From 1 August, Vitrakvi® (larotrectinib) will be made available through the Pharmaceutical Benefits Scheme (PBS) for the treatment of advanced non-small cell lung cancer, soft tissue sarcomas and brain (glioma, glioneuronal tumour or glioblastoma) tumours that have the NTRK (neurotrophic tyrosine receptor kinase) gene fusion.1 NTRK gene fusion is identified through a genetic test, such as genomic sequencing.
Eligible patients will pay just $7.70 (concession) or $31.60 (general patients) each month for Vitrakvi.3 Without a PBS listing, the medicine would cost around $130,000 per year.4
NTRK fusion is a genetic mutation that occurs when two different genes fuse together. It happens for no apparent reason and acts as an ‘ignition switch’ for tumour growth.5 Cancers with NTRK fusion can occur anywhere in the body, in both children and adults.
Vitrakvi works by blocking the protein that is produced following the fusion process, thereby halting tumour development and growth.2
Around one-in-five cancers are caused by ‘gene fusions’.6 These cancers often respond poorly to non-targeted treatments, whereas precision medicine, can be used to treat cancers with a particular genetic feature regardless of the type of cancer or where it is found in the body.
The reimbursement of Vitrakvi for Australians with NTRK fusion sarcoma, brain or lung cancer, comes at a time when precision medicine is becoming more commonplace as testing for biomarkers increases.
Vitrakvi will be reimbursed for the treatment of patients with non-small cell lung cancer, soft tissue sarcoma and brain (glioma, glioneuronal tumour or glioblastoma) cancer with locally advanced or metastatic solid tumours that:1
- Have an NTRK gene fusion without a known acquired resistance mutation,
- Are metastatic (advanced) or where surgical resection is likely to result in severe morbidity, and
- Have either progressed following treatment or who have no satisfactory alternative therapy.
Since July 2022, the medicine has been subsidised through the PBS for the treatment of children aged from one-month diagnosed with NTRK positive tumours, as well as for adults with NTRK positive rare cancers, including advanced mammary analogue secretory carcinoma (a form of salivary gland cancer) and secretory breast cancer.1
The new subsidy will see the medicine used for more common cancers, which are less frequently caused by NTRK gene fusions.1,7
In the last decade, more than 23,000 patients have been enrolled in Bayer’s oncology clinical trials around the world.8 In Australia, Bayer has invested more than $10 million since 2019 to support 11 oncology clinical trials across 54 sites. These trials enrolled 83 Australian patients, including four with NTRK positive tumours enrolled in trials to assess the impact of Vitrakvi on cancer progression and survival.9
About VITRAKVI
As with all medicines, Vitrakvi is associated with some side-effects. While uncommon, the most frequent adverse events are fatigue, dizziness, nausea, vomiting, constipation, myalgia, muscular weakness, anaemia, neutrophil count decreased (neutropenia), leukocyte count decreased (leukopenia), aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased and weight increase (abnormal weight gain).2
Vitrakvi is not suitable for patients with hypersensitivity to the medicine or other substances in the formulation. Caution is required in relation to neurologic reactions, elevated liver enzymes, liver impairment, kidney impairment and laboratory tests abnormalities. The following medicines may influence the effect of Vitrakvi, or Vitrakvi may influence the effect of these medicines: CYP3A, P-gp and BCRP Inhibitors, CYP3A and P-gp Inducers and CYP3A substrates. These medicines are used to treat bacterial infections, HIV, seizures, depression, pain, organ transplant rejection, abnormal heart rhythms, migraine, and motor or verbal tics.2
About NTRK gene fusion cancer
NTRK gene fusions occur when a piece of the chromosome containing a gene called NTRK breaks off and joins with another gene. NTRK gene fusions lead to abnormal proteins called TRK (tropomyosin receptor kinase) fusion proteins, which may cause cancer cells to form and grow rapidly.2,10
A confirmatory NTRK fusion diagnosis is performed through genetic testing of tissue using RNA or DNA next-generation sequencing (NGS) or fluorescence in situ hybridization (FISH).11 Only patients with confirmed NTRK gene fusion in their tumour are eligible for treatment with Vitrakvi.2
About precision medicine
Precision medicine is a tailored approach to disease prevention and treatment that takes into account differences in people’s genes, environments, and lifestyles. It is underpinned by genetic and genomic testing (sequencing), the results of which enable better prediction, prevention, diagnosis and treatment of disease.12
About Bayer in Australia
Bayer is a global enterprise with core competencies in the life science fields of health care, nutrition and agriculture. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. The company has operated in Australia since 1925 and has a long-term commitment to the health and nutrition of all Australians. Locally, Bayer employs almost 900 people across the country and is dedicated to servicing the needs of rural and remote communities. Bayer embraces and encourages its employees’ unique identities and advances a culture of inclusion and diversity across gender, LGBTQI+, generations, disability and race. For more information, go to www.bayer.com.au
From 1 August 2024
VITRAKVI® is listed on the PBS.
Refer to the PBS schedule for more information www.pbs.gov.au.
Consumer Medicine Information for Vitrakvi® is available here.
Full Product Information for Vitrakvi® is available here.
Media Contacts:
Amy Appleton (0497 863 707) at Bayer; or
Rebecca Anable (0404 019 323) at Ethical Strategies.
References
1. Schedule of Pharmaceutical Benefits. Available at: https://www.pbs.gov.au/pbs/
2. Bayer Australia. VITRAKVI Product Information. October 2023.
3. Australian Government Department of Health and Aged Care. About the PBS. 2024. Last accessed June 2024
4. Bayer Australia. Data on File – PBS List Price for Vitrakvi. July 2024
5. Hong, D. et al. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncology, 2020;21(4). DOI: 10.1016/S1470-2045(19)30856-3
6. Heyer, E. et al. Diagnosis of fusion genes using targeted RNA sequencing. Nature Communications, 2019;10(1). DOI: 10.1038/s41467-019-09374-9
7. O'Haire S, Franchini F, Kang YJ, Steinberg J, Canfell K, Desai J, Fox S & Ijzerman M 2023. Systematic review of NTRK 1/2/3 fusion prevalence pan-cancer and across solid tumours. Sci Rep, 13
8. Bayer AG. Data on File – Bayer Oncology International Clinical Trial Involvement. June 2024.
9. Bayer Australia. Data on File – Bayer AU Oncology R&D Investment. June 2024
10. Vaishnavi, A. et al. TRKing down an old oncogene in a new era of targeted therapy. Cancer Discovery, 2015;5(1). DOI: 10.1158/2159-8290.CD-14-0765
11. Lassen, U. How I treat NTRK gene fusion-positive cancers. ESMO Open, 2019;4(2): e000612. DOI: 101136/esmoopen-2019-000612
12. Riess, O., Sturm, M., Menden, B. et al. Genomes in clinical care. npj Genom. Med. 9, 20 (2024). https://doi.org/10.1038/s41525-024-00402-2
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer Australia Pty Ltd, ABN 22 000 1 38 714, 875 Pacific Highway, Pymble NSW 2073.
Ph: (02) 9391 6000. Date of Preparation: July 2024. COR-VIT-AU-0040-1