BMS Reports sNDA Accpetance with Priority Review by the US FDA for Augtyro to Treat Solid Tumors
Shots:
- The US FDA has accepted BMS’ sNDA for Augtyro (repotrectinib) to treat patients with NTRK+ locally advanced or metastatic solid tumors where surgical removal can lead to severe morbidity. The decision is expected in Jun 2024
- The acceptance was based on results from the two P-I/II (TRIDENT-1 & CARE) studies assessing Augtyro’s safety, tolerability, PK and anti-tumor activity in adult and pediatric patients (12yrs. & older) with NTRK+ locally advanced or metastatic solid tumors
- Results from the TRIDENT-1 trial revealed favorable response rates in NTRK+ solid tumor patients, with strong DoR and intracranial responses. The study is in progress for further evaluation. The CARE study supported these results
Ref: BMS | Image: BMS
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
