The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib) for neurotrophic tyrosine receptor kinase (NTRK)-positive locally advanced or metastatic solid tumours.

The treatment is indicated for use in adult and paediatric patients aged 12 years and above with tumours when surgical resection could cause severe morbidity, and for those who have either progressed following treatment or lack satisfactory alternative therapies.

The FDA approved Augtyro based on the outcomes from the Phase I/II TRIDENT-1 study.

The trial assessed the drug’s efficacy in adults with NTRK-positive solid tumours, demonstrating promising results in overall response rate and duration of response.

However, the FDA’s accelerated approval stipulates that continued authorisation may depend on further verification and description of clinical benefits from confirmatory trials.

The open-label, multi-cohort trial was conducted globally across multiple centres assessing Augtyro’s safety, tolerability, pharmacokinetics and anti-tumour activity.

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The study included patients who had not previously received tyrosine kinase inhibitors (TKIs) and those previously treated with TKIs.

The recommended Augtyro dosage for paediatric patients aged 12 and older and for adults is 160mg oral once a day for 14 days, followed by 160mg twice a day until progression of disease or unacceptable toxicity occurs.

In the US, this second indication for Augtyro follows a full approval for treating adults with locally advanced or metastatic ROS1-positive NSCLC in November 2023.

Bristol Myers Squibb Medical Oncology senior vice-president Nick Botwood stated: “The FDA approval of Augtyro for patients with NTRK-positive tumours adds to its indication in ROS1-positive NSCLC, showing its clinical value for more people across multiple genetic markers.

“Previously, there was not an FDA-approved treatment option for NTRK-positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumours. This milestone helps address this area of unmet need and builds on Bristol Myers Squibb’s longstanding legacy of bringing innovations to individuals who are facing cancer and urgently seeking new treatment options.”

In May 2024, BMS received FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel) to treat adults with relapsed or refractory mantle cell lymphoma (MCL).