Cometriq
Oncology· 439 cited findings· 1 source document
Company: Ipsen S.A.
What the regulatory reviews say
Cometriq (cabozantinib) is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. The Marketing Authorisation application was submitted on 29 October 2012, and a conditional Marketing Authorisation received a positive opinion from the CHMP on 19 December 2013. The drug received Orphan medicinal product designation on 6 February 2009.
In efficacy trials, Cometriq demonstrated a median progression-free survival (PFS) of 11.2 months in the cabozantinib arm compared to 4.0 months in the placebo arm. The PFS Hazard Ratio was 0.28 (95% CI: 0.19-0.40, p-value <0.0001). At 12 months, the PFS rate was 47.3% for the cabozantinib arm versus 7.2% for the placebo arm. A total of 139 PFS events were observed, with 79 in the cabozantinib arm and 60 in the placebo arm.
Safety data from 295 patients treated with cabozantinib showed that 75% of patients required at least one dose reduction, and 41% required two dose reductions. The median time to the first dose reduction was 43 days. Hypertension was reported in 29.4% of patients in the cabozantinib arm.
Key figures — cited to the source page
| Median PFS (cabozantinib arm) | 11.2 months | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.55 |
| Median PFS (placebo arm) | 4.0 months | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.55 |
| PFS Hazard Ratio | 0.28 | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.55 |
| PFS 95% CI | 0.19-0.40 | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.55 |
| PFS p-value | <0.0001 | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.55 |
| Patients requiring at least one dose reduction | 75 % | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.67 |
| Median time to first dose reduction | 43 days | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.86 |
| CHMP positive opinion date for conditional Marketing Authorisation | 19 December 2013 | Ipsen S.A. — Cometriq EMA EPAR public assessment report (EME, p.7 |
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.