2022 – For the first time, Australian children will receive government funded access to a medicine and matching genetic test that enables the underlying cause of multiple NTRK gene fusion cancers to be treated.1,2
From 1 July, Vitrakvi® (larotrectinib) will be made available through the Pharmaceutical Benefits Scheme (PBS) for the treatment of children aged from one-month diagnosed with NTRK (neurotrophic tyrosine receptor kinase) positive tumours, as well as for adults with NTRK fusion positive advanced mammary analogue secretory carcinoma (a form of salivary gland cancer) and secretory breast cancer.1
Importantly, Medicare funding is also being provided for the genetic testing required to identify NTRK gene fusion, an essential step before treatment with Vitrakvi can be considered.2
Eligible patients will pay just $6.80 (on concession) or $42.50 (general patients) each month for Vitrakvi.3 Without a PBS listing, the medicine would cost around $100,000 per year, and the diagnostic NTRK fusion test can cost up to $2,000.4
Associate Professor Jordan Hansford, a Clinical Oncologist and children’s brain cancer specialist, welcomed the reimbursement of Vitrakvi and NTRK fusion genetic testing, noting the impact that targeted precision medicines can have on patients.
“Cancer is fundamentally a disease of the DNA; and cancer treatment is increasingly focused on what’s driving the cancer, rather than where the cancer is located in the body,” said Professor Hansford.
“We know that genetic information holds the key to optimal treatment, which is why this two-fold funding approach to testing and treatment is so important,” he said. “It allows us to get the right medicine to the right patient at the right time.”
NTRK fusion is a specific genetic change that occurs for no apparent reason and acts as an ‘ignition switch’ for tumour growth.5 Vitrakvi works by blocking the protein that is produced following the fusion process, thereby halting tumour development.6
Cancers with NTRK fusion can occur anywhere in the body, in both children and adults. NTRK fusion is most common in several forms of childhood cancer, as well as in salivary gland (mammary analogue secretory carcinoma) and secretory breast cancer.5,7,8
Professor Hansford explained that ‘gene fusions’ are responsible for an estimated one-in-five cancers9 and that “the impact of affordable access to genetic testing and targeted treatment can be profound for patients”.
The Kids’ Cancer Project Chief Executive, Owen Finegan said, “This is a big moment for some very young cancer patients with hard-to-treat tumours.”
“Every day, three families discover their child has cancer and this disease remains the number one cause of death of Australian children,”10 he said.
“Treating children’s cancer has long been a balancing act, using aggressive chemotherapy and radiotherapy while working to minimise the potential for long-term or developmental side-effects.
“Precision medicine offers great potential for kids, as well as adults with cancer. Genetic testing gives doctors more detail about what is driving the cancer and can guide treatment approaches to target the cause of the disease,” Mr Finegan said.
Bayer ANZ General Manager for Pharmaceuticals, Ashraf Al-Ouf said his company shared the community’s excitement about subsidised access to this new treatment option and genetic test.
“Vitrakvi is the first precision medicine of its kind in Australia that makes it possible to treat advanced NTRK fusion positive cancer regardless of the patient’s age or the location of the cancer,” he said.
“This is a major milestone for Australians with NTRK fusion positive cancers as many will now be able to access this important medicine through the PBS. At Bayer we are researching and investing in transformative healthcare treatments that have the potential to help Australian cancer patients with unmet needs,” said Mr Al-Ouf.
Vitrakvi is provisionally approved in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:6
- have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
- are metastatic or where surgical resection is likely to result in severe morbidity, and
- have either progressed following treatment or who have no satisfactory alternative therapy.
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).6
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.6
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.6,7
A confirmatory NTRK fusion diagnosis is performed through genetic testing of tissue using RNA or DNA next-generation sequencing (NGS) or fluorescence in situ hybridisation (FISH).11 Only patients with confirmed NTRK gene fusion in their tumour are eligible for treatment with Vitrakvi.6
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 healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life. It has operated in Australia since 1925 and has a long-term commitment to the health of Australians. Locally, Bayer currently employs almost 900 people across the country and is dedicated to servicing the needs of rural Australia and the local community. Bayer is deeply committed to research and development and has a strong tradition of innovation. The company’s focus on people, partnerships and innovation underpins all aspects of its operations, consistent with its mission, “Bayer: Science For A Better Life.” www.bayer.com.au