Bristol Myers Squibb (BMS) has received accelerated approval from the US Food and Drug Administration (FDA) for Augtyro (repotrectinib) to treat patients with certain solid tumours.
FDA has approved Augtyro, a next-generation tyrosine kinase inhibitor (TKI), for patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
These tumours must be locally advanced or metastatic or be in a state where surgical removal is expected to cause severe morbidity.
Additionally, patients must have either progressed after treatment or have no satisfactory alternative therapy available.
The approval is supported by findings from the global, multicentre, single-arm, open-label, multi-cohort Phase 1/2 TRIDENT-1 study.
In the TRIDENT-1 trial, both TKI-naïve and TKI-pretreated patients with NTRK-positive locally advanced/metastatic solid tumours, encompassing 15 different cancer types, were studied.
Among TKI-naïve patients, 58% achieved a confirmed objective response rate (cORR).
Out of these, 43% experienced partial responses (PR) and 15% achieved complete responses (CR).
In addition, 83% of TKI-naïve responders remained in response at one year with Augtyro, while the median duration of response (mDOR) was not yet reached.
For TKI-pretreated patients, the cORR was 50%, with 50% experiencing PR and no patients achieving CR.
Additionally, 42% of TKI-pretreated responders remained in response at one year with Augtyro.
Bristol Myers Squibb Medical Oncology senior vice president Nick Botwood said: “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.”
The safety and efficacy of Augtyro haven’t been established in paediatric patients under 12 years old with solid tumours with NTRK gene fusion.
Continued approval for this indication is subject to further verification and description of clinical benefits in confirmatory trials.
The approval marks the second indication for Augtyro in the US. Earlier it received full approval to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in November 2023.
