Bristol Myers Squibb (BMS) moved another step closer to expanding the use of its targeted therapy Augtyro (repotrectinib) after its supplemental new drug application (sNDA) to include other cancers that have NTRK fusions was accepted.
Augtyro is an orally administered tyrosine kinase inhibitor (TKI) that is already approved to treat adults with ROS1+ non-small cell lung cancer (NSCLC). The company filed the sNDA based on data from the Phase I/II TRIDENT 1 trial (NCT03093116) and the Phase I/II CARE trial (NCT04094610), where the targeted therapy’s efficacy was tested in neurotrophic receptor tyrosine kinase (NTRK)-positive solid tumours.
The agency has also granted priority review status to the application with an assigned target action date of 15 June 2024. Under the priority review, the FDA aims to issue a decision on the application within six months, instead of ten months for standard review.
In the TRIDENT 1 and CARE studies, Augtyro showed promising response rates for delivering durable responses, and tackling common resistance mutations. The safety profile is well understood and manageable with standard treatments.
According to a market model on GlobalData’s Pharma Intelligence Center, Augtyro is forecast to generate $655m in sales in 2029. GlobalData is the parent company of Pharmaceutical Technology.
Augtyro is not the only targeted therapy that has been designed for a tumour-agnostic use. In 2019, Bayer’s Vitrakvi (larotrectinib) gained an FDA approval for patients with solid tumours with NTRK fusions, regardless of the tumour type. In November 2023, Bayer had to recall a single lot of Vitrakvi oral solution 20mg/mL, available in 100mL glass bottle, following the detection of microbial contamination with Penicillium brevicompactum during routine stability inspections.
Roche’s Rozlytrek (entrectinib), another targeted therapy, is approved to treat both solid tumours with NTRK fusions and ROS1+ NSCLC.
In August 2023, China’s National Medical Products Administration’s Center for Drug Evaluation granted breakthrough therapy designation to Augtyro to treat patients with NTRK-positive advanced solid tumours, also based on the TRIDENT-1 study.
In the announcement accompanying the sNDA, vice president at BMS Joseph Fiore said: “We look forward to working closely with the FDA on the review of our application for Augtyro for this tumour-agnostic indication and potentially offering patients with NTRK-positive disease a new, durable treatment option.”
