VITRAKVI

What it is

VITRAKVI is available as 25 mg hard capsules, 100 mg hard capsules, and 20 mg/mL oral solution, each containing larotrectinib sulfate. VITRAKVI is for oral use and is available as a capsule or oral solution formulation with equivalent oral bioavailability, and may be used interchangeably.

Approved indications

— 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.

Dosing overview

The recommended dose of VITRAKVI in adults is 100 mg taken orally, twice daily until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. In paediatric patients (1 month to 18 years), dosing is based on body surface area, with a recommended dose of 100 mg/m² taken orally, twice daily with a maximum of 100 mg per dose until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Key safety warnings

The approval has been made on the basis of objective response rate and duration of response from single arm clinical studies, and the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

Contraindications

The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI.

PBS listing

VITRAKVI is listed on the PBS with authority required restriction. The 25 mg capsule is listed with an ex-manufacturer price of A$2475.00, the 100 mg capsule with an ex-manufacturer price of A$9900.00, and the 20 mg/mL oral solution with an ex-manufacturer price of A$3300.00. Each strength has 4 PBS items.

Regulatory history

VITRAKVI 25 mg and 100 mg hard capsules were first listed on the ARTG on 7 September 2020, and the 20 mg/mL oral solution was first listed on 20 September 2022. VITRAKVI received provisional approval in Australia on 27 August 2020 for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours harbouring an NTRK gene fusion. In November 2021, the PBAC deferred consideration for the paediatric and adult high frequency NTRK fusion population and did not recommend it for the adult low frequency NTRK fusion population. A subsequent submission was withdrawn in March 2023, and in March 2024 VITRAKVI was recommended by the PBAC for non-small cell lung cancer or soft tissue sarcoma harbouring NTRK gene fusions.