Esteve S A — Caprelsa EMA EPAR variation assessment report (EMEA/H/C/002315, 2012)
Esteve S A · 2012 · EMA EPAR variation assessment report
Report summary
This report summarizes the annual renewal of the conditional marketing authorization for Caprelsa (vandetanib) for RET mutant medullary thyroid cancer. It confirms a positive benefit-risk balance, addressing specific obligations like reanalysis of RET mutation status in a pivotal study (ZETA) and an observational study. The report also covers safety updates, including labeling changes for renal failure and impaired wound healing, and requirements for educational materials. A key point of contention remains the benefit-risk balance in RET-negative patients, with the Marketing Authorization Holder asserting a positive balance despite the CHMP rapporteur's disagreement.
Key findings — cited to the page
| PFS HR | 0.21 | ZETA study (reanalysis of RET negative patients) · p.16 |
| estimated paediatric patient interval exposure to CAPRELSA | 90 | CAPRELSA · Europe · p.19 |
| 2-year PFS rate | 40.1% | ZETA study · p.15 |
| objective tumor response | 0% | ZETA study (reanalysis of RET negative patients) · p.16 |
| two-year PFS rate | 90% | ZETA study (reanalysis of RET negative patients) · p.16 |
| two-year PFS rate | 50% | ZETA study (reanalysis of RET negative patients) · p.16 |
| PFS hazard ratio | 0.46 | ZETA study · p.15 |
| 2-year PFS rate | 55.7% | ZETA study · p.15 |
| objective tumor response | 18.2% | ZETA study (reanalysis of RET negative patients) · p.16 |
| overall response rate (ORR) | 51.7% | ZETA study · p.15 |
| overall response rate (ORR) | 14.9% | ZETA study · p.15 |
| Serious Adverse Events (SAEs) reported from MAH-sponsored clinical trials | 4491 | · p.20 |
Source: Esteve S A ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →