Augtyro(repotrectinib)
Oncology· 2957 cited findings· 2 source documents
Company: Bristol-Myers Squibb Company →
What the regulatory reviews say
Augtyro (repotrectinib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. The drug received its initial approval on November 15, 2023, with a PDUFA Goal Date of June 15, 2024, for a supplemental New Drug Application (sNDA) which was received on December 15, 2023. Augtyro has been granted Orphan Designation (17-5735).
Efficacy data show a Confirmed Overall Response Rate of 79% with 6% Complete Response and 73% Partial Response, and a Median Duration of Response of 34.1 months. For patients with EML4-NTRK3 fusion, the Overall Response Rate was 80%. Notable safety findings include Skeletal Fractures (3.5% in TRIDENT-1, 18.4% in CARE), QT prolongation (0.9% in TRIDENT-1, 15.8% in CARE), and Pneumonitis (3.2% in TRIDENT-1, 0% in CARE).
Key figures — cited to the source page
| Confirmed Overall Response Rate | 79 | Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 2, p.32 |
| Median Duration of Response | 34.1 | Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 2, p.32 |
| ORR for EML4-NTRK3 fusion | 80 | Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 2, p.137 |
| Skeletal Fractures (TRIDENT-1) | 3.5 | Bristol-Myers Squibb Company — Augtyro EMA EPAR public asses, p.193 |
| Skeletal Fractures (CARE) | 18.4 | Bristol-Myers Squibb Company — Augtyro EMA EPAR public asses, p.193 |
| Pneumonitis (TRIDENT-1) | 3.2 | Bristol-Myers Squibb Company — Augtyro EMA EPAR public asses, p.193 |
| NDA 218213 Initial Approval Date | November 15, 2023 | Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 2, p.279 |
| Orphan Designation | 17-5735 | Bristol-Myers Squibb Company — Augtyro FDA Review (NDA/BLA 2, p.258 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.