Kadcyla
Oncology· 1542 cited findings· 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Kadcyla is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for advanced disease or developed disease recurrence during or within six months of completing adjuvant therapy. The recommended dose is 3.6 mg/kg.
In a Phase III trial, the IRC-assessed objective response rate (ORR) for Kadcyla was 32.7%, with a partial response rate of 32.7% and a complete response rate of 0.0%. The median duration of objective response was 9.7 months. The median progression-free survival (PFS) for Kadcyla was 14.2 months, with a hazard ratio for PFS of 0.594 (95% CI: 0.364, 0.968; p-value: 0.0353).
The median treatment duration for Kadcyla (T-DM1) was 10.4 months, with a median dose intensity of 99.9%. Kadcyla received a favorable marketing authorization recommendation on September 19, 2013, following an application submission on August 30, 2012, and was qualified as a new active substance.
Key figures — cited to the source page
| IRC-assessed ORR | 32.7 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.70 |
| Median duration of objective response | 9.7 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.70 |
| Median Progression-free survival | 14.2 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.74 |
| Hazard ratio for PFS | 0.594 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.74 |
| p-value for PFS | 0.0353 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.74 |
| Median treatment duration for T-DM1 | 10.4 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.79 |
| Marketing Authorisation opinion date | 19 September 2013 | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.8 |
| New Active Substance Status | qualified as a new active substance | Roche Holding AG — Kadcyla EMA EPAR public assessment report, p.120 |
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.