Bristol Myers Squibb’s Augtyro granted expanded FDA approval for solid tumours
14 Jun 2024
Drug ApprovalClinical ResultImmunotherapyCell TherapyAcquisition
Preview
Source: PMLiVE
Bristol Myers Squibb’s Augtyro (repotrectinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat neurotrophic tyrosine receptor kinase (NTRK)-positive tumours.
The tyrosine kinase inhibitor (TKI) has been specifically authorised for use in adult and paediatric patients aged 12 years of age and older with tumours that are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, who have progressed following treatment or have no satisfactory alternative therapy.
Augtyro, which was added to BMS’ oncology portfolio in 2022 through its $4.1bn acquisition of Turning Point Therapeutics, was approved by the FDA last November to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The FDA’s latest decision on the drug was supported by positive results from the phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adults with NTRK-positive solid tumoursNTRK-positive solid tumours.
At a median follow-up of 17.8 months, 58% of Augtyro-treated patients who had not previously received any TKI treatment had a confirmed objective response rate. In TKI-pretreated patients, with a median follow-up of 20.1 months, the confirmed objective response rate was 50%.
After one year of Augtyro treatment, 83% of TKI-naïve responding patients and 42% of TKI-pretreated responding patients were still in response.
“NTRK fusion-positive tumoursNTRK fusion-positive tumours can present challenges in the clinical setting, which is why it is important that we have additional treatment options for these patients,” explained TRIDENT-1 global trial lead, Alexander Drilon, Memorial Sloan Kettering Cancer CenterCancer Center.
He continued: “The FDA approval of [Augtyro] adds an important tool to our toolbox, offering oncologists a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumoursNTRK fusion-positive solid tumours for both TKI-naïve and TKI-pretreated patients.”
The decision comes just two weeks after the FDA approved BMS’ CAR T cell therapy Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitorBruton tyrosine kinase inhibitor.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.