Caprelsa(vandetanib)
Oncology· 381 cited findings· 2 source documents
Company: Esteve S A
What the regulatory reviews say
Caprelsa (vandetanib) is an active substance with New Active Substance Status, developed by AstraZeneca AB. It is approved for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is available in 100 mg and 300 mg tablet strengths for oral use.
In a clinical trial, vandetanib demonstrated a median Progression-Free Survival (PFS) of 30.5 months compared to 19.3 months for placebo, representing an increase of 11.2 months. The PFS Hazard Ratio (vandetanib vs placebo) was 0.46 (95% CI: 0.31 to 0.69) with a logrank p-value of 0.0001. The objective response rate in patients with no M918T mutation and no other identified mutation was 35% with a duration of response of 18 months. Notable safety findings include a half-life of 19 days and specific ECG QTc interval thresholds for not starting (480 msec) and stopping (500 msec) vandetanib.
Key figures — cited to the source page
| PFS Hazard Ratio (vandetanib vs placebo) | 0.46 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.6 |
| PFS Hazard Ratio 95% CI | 0.31 to 0.69 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.6 |
| median PFS (vandetanib) | 30.5 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.6 |
| median PFS (placebo) | 19.3 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.6 |
| median PFS increase vs placebo | 11.2 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.6 |
| PFS logrank p-value | 0.0001 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.39 |
| Half-life | 19 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.10 |
| ECG QTc interval threshold for stopping vandetanib | 500 | Esteve S A — Caprelsa EMA EPAR public assessment report (EME, p.87 |
Source documents
Explore the full evidence
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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.