VITRAKVI (Bayer Australia Ltd)

VITRAKVI (hard capsule, oral liquid) 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.