FDA grants approval for Bristol Myers Squibb’s Augtyro for solid tumours

14 Jun 2024
www.pharmaceutical-technology.com
Drug ApprovalAccelerated Approval
Bristol Myers Squibb’s Augtyro is intended for treating NTRK-positive locally advanced or metastatic solid tumours. Credit: Tada Images / Shutterstock.
Bristol Myers Squibb AdAugtyroation (FDA) has granted acNTRK-positive locally advanced or metastatic solid tumoursNTRKrated approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib) for neurotrophic tyrosine receptor kinase (NTRK)-positive locally advanced or metastatic solid tumours.
The treFood and Drug Administration (FDA)lt and paediatric patients aged 12 yeaBristol Myers Squibbmours when surgical resection could cneurotrophic tyrosine receptor kinase (NTRK)-positive locally advanced or metastatic solid tumoursactory alternative therapies.
The FDA approved Augtyro based on the outcomes from the Phase I/II TRIDENT-1 study.tumours
The FDAal assesseAugtyrorug’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 thaNTRK-positive solid tumoursNTRKntinued authorisation may depend on further verification and description of clinical benefits from confirmatory trials.
See Also:MonlFDAbant by Inversago Pharma for Obesity: Likelihood of Approval
MonlunabaMonlunabantsagoInversago PharmabolicObesityme: Likelihood of Approval
The open-label, multi-cohort trial was conducted globally across multiple centres assessing Augtyro’s safety, tolerability, pharmacokinetics and anti-tumour activity.
The study incluInversago Pharma had Metabolic Syndromeeived 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 wiAugtyrolly advanced or metastatic ROS1-positive NSCLC in Ntumourr 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, theAugtyronot 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 approvalAugtyroeyanzi (lisocabtagene maraleucel; liso-cel) to treat adults with relapsed or refrROS1-positive NSCLCROS1-positive cell lymphoma (MCL).
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
Targets
Drugs
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
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. Empower better decisions with the latest in pharmaceutical intelligence.