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Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, 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.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, 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.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, 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.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, 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.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
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