| Product class | Xenogeneic plasmid DNA vaccine (human tyrosinase) | Live attenuated Listeria vector expressing chimeric HER2 | Caninized anti-PD-1 monoclonal antibody |
| Indication at licensure | Stage II–III oral melanoma, locoregional control achieved | Osteosarcoma, dogs ≥ 1 year old | Stage I–III mast cell tumor (MCT); stage II–III melanoma |
| Conditional license | 22 March 2007 (CVB Notice 07-03) | December 2017 (CVB Notice 17-16) | Between Dec 2022 and Oct 2023; initially product code 9790.00, current code 9790.02 (Intervet 65A); no numbered CVB notice identified |
| Supporting study design | Uncontrolled phase I (n = 9), stage II–IV | Uncontrolled (n = 18), vs historical control | Uncontrolled open-label (n = 51), +15 lymphoma |
| Comparative basis in the licensure record | None in the publicly available USDA record (n = 9 at conditional licensure; n = 53 at conversion) | Historical control | None |
| Reported effect | Kaplan–Meier median survival 389 d (3 of 9 censored) | Median survival 956 d vs 423 d (p<0.05) | Melanoma ORR 20% (95% CI, 7%–41%); MCT ORR 46% (95% CI, 27%–67%); lymphoma ORR 0% |
| Confirmatory obligation | Written commitment to complete efficacy studies | Extended field study required | Larger registration trial reported to be ongoing |
| Peer-reviewed publication relative to licensure | Phase I published 2003, before conditional license; the efficacy study recorded by USDA for conversion is unpublished; comparative study of a different cohort published 2011 | Phase I published 2016, before conditional license | Published 5 June 2026, at least 2.5 years after conditional license |
| Outcome of confirmatory phase | Converted to regular license (February 2010) | Product discontinued by sponsor (January 2020) | Pending |
| Independent or confirmatory evidence | Retrospective studies did not reproduce a survival advantage | COTC026 (n = 118): DFI 217 vs 180 d (p=0.33); overall survival 341 vs 282 d (p=0.10) | Not yet available |
| Current status | Regularly licensed (CVB product code 9240.D0) | Discontinued; not licensed | Conditionally licensed |