Herceptin(trastuzumab)
Oncologyยท 452 cited findingsยท 3 source documents
Company: Roche Holding AG โ
What the regulatory reviews say
Herceptin (trastuzumab) is a pharmaceutical agent with a strength of 600 mg / 5 mL, administered via subcutaneous use. It is classified under the ATC Code L01XC03. Regulatory approval for Herceptin was granted on April 27, 2017, following a BLA submission on November 4, 2016 (BLA number 103792/S-5337).
Efficacy findings from a Phase III trial involving 596 patients demonstrated that 98.7% of patients in the IV arm and 97% in the SC arm had a Ctrough > 20 ฮผg/mL at pre-dose Cycle 8. The geometric mean Ctrough ratio (SC/IV) at pre-dose Cycle 8 was 1.24, and at pre-dose Cycle 13, it was 1.51. The absolute bioavailability (AUC0-inf) ranged from 83.9% to 98.6%. The median AUC exposure (Cycle 12) for SC administration was 2470 ยตg*day/ml.
Safety data indicates that Grade 3 or higher adverse reactions occurred in 16.3% to 20.4% of patients. Asymptomatic cardiac dysfunction rates ranged from 4.6% to 8.1%. Other notable adverse events (Grade 2-5) included infection (12.8% to 24.0%), fatigue (29.5%), edema (2.7% to 4.7%), and pain (3.0%).
Key figures โ cited to the source page
| Approval Date | April 27, 2017 | GENENTECH โ Herceptin FDA Review (NDA/BLA 103792, 2017), p.1 |
| BLA Number | 103792/S-5337 | GENENTECH โ Herceptin FDA Review (NDA/BLA 103792, 2017), p.4 |
| patients with Ctrough > 20 ฮผg/mL at pre-dose Cycle 8 (IV arm) | 98.7 | Roche Holding AG โ Herceptin EMA EPAR variation assessment r, p.35 |
| patients with Ctrough > 20 ฮผg/mL at pre-dose Cycle 8 (SC arm) | 97 | Roche Holding AG โ Herceptin EMA EPAR variation assessment r, p.35 |
| geometric mean Ctrough ratio (SC/IV) at pre-dose Cycle 8 | 1.24 | Roche Holding AG โ Herceptin EMA EPAR variation assessment r, p.35 |
| Grade 3 or higher adverse reactions | 16.3% | GENENTECH โ Herceptin FDA Review (NDA/BLA 103792, 2017), p.18 |
| asymptomatic cardiac dysfunction rate | 4.6% | GENENTECH โ Herceptin FDA Review (NDA/BLA 103792, 2017), p.18 |
| fatigue (Grade 2-5) | 29.5% | GENENTECH โ Herceptin FDA Review (NDA/BLA 103792, 2017), p.18 |
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 โ values are not head-to-head comparisons). Educational reference only โ not medical or investment advice.