Bayer’s Vitrakvi (larotrectinib) has been granted traditional approval by the US Food and Drug Administration (FDA) to treat neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive solid tumours.
The TRK inhibitor is now fully authorised for use in adult and paediatric patients with solid tumours that do not have a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment.
The FDA first approved Vitrakvi in 2018 under its accelerated approval pathway, under which the US regulator may approve therapies for serious diseases like cancer earlier, on the condition that companies conduct studies to confirm the anticipated clinical benefit.
Tumours with NTRK gene fusion produce an altered TRK protein, which causes the uncontrolled growth of cancer cells. Vitrakvi is designed to block the action of this protein to prevent the excessive growth of cancer cells and slow the worsening of the disease.
TRK fusion cancer can occur in any part of the body, including the lungs, thyroid, colon, pancreas and salivary glands.
Commenting on the authorisation, Andrea Ferris, president and chief executive officer of the non-profit lung cancer foundation LUNGevity, said: “The full approval of Vitrakvi by the FDA is a welcome step forward, solidifying its place as a treatment option for patients with NTRK gene fusion-positive cancers.
“This milestone not only benefits patients today but also paves the way for further advancements in NTRK gene therapies in the future.”
The FDA’s latest decision on Vitrakvi was supported by positive data from three open-label trials, which included adult and paediatric patients with unresectable or metastatic solid tumours with an NTRK gene fusion.
Pooled efficacy results demonstrated an overall response rate of 60%, a complete response rate of 24% and a partial response rate of 36% for Vitrakvi-treated patients, as well as median duration of response of 43.3 months.
Chandra Goda, executive director, US Vitrakvi brand lead, said: “This first full approval of an NTRK inhibitor by the FDA represents the culmination of research and dedication by the Bayer team.”