BMS scores tumour-agnostic nod for Augtyro across NTRK fusion cancers NTRK fusion cancers

2024-06-13

优先审批上市批准并购临床结果加速审批

Bristol Myers Squibb's Augtyro (repotrectinib) has secured an accelerated approval from the FDA for the treatment of adult and paediatric patients aged 12 years and older with solid tumours harbouring NTRK gene fusions.

The decision announced Thursday marks the drug's second indication after gaining US approval for ROS1-positive non-small-cell lung cancer (NSCLC)ROS1-positive non-small-cell lung cancer (NSCLC) last November. Chinese regulators recently cleared the drug in this indication as well.

The broader US label is specifically for patients with NTRK fusion-positive cancer NTRK fusion-positive cancer that is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have progressed following treatment or have no satisfactory alternative therapy.

The filing, which was assessed under a priority review, was based on data from the Phase I/II single-arm TRIDENT-1 trial that evaluated Augtyro in 88 adult patients with locally advanced or metastatic NTRK gene fusion-positive solid tumours. The study included patients who had either received a prior TRK tyrosine kinase inhibitor (TKI)TRK tyrosine kinase inhibitor (TKI) or were TKI-naïve.

Augtyro demonstrated a confirmed overall response rate (ORR) of 58% among TKI-naïve patients and 50% in the TKI-pretreated group. Additionally, the duration of response was not estimable in the TKI-naïve arm and was 9.9 months among those who had previously been treated with a TKI.