Herceptin (trastuzumab) 600mg/5ml solution for subcutaneous injection reduces administration time to 2–5 minutes compared with the 30–90 minutes needed for intravenous infusion. In addition, the subcutaneous formulation is given in a fixed treatment regimen of 600mg every three weeks, in contrast to the dose for intravenous administration which must be calculated on the basis of body weight.
Breast cancer use only
The new formulation is licensed for use only in HER2-positive metastatic or early breast cancer. The intravenous preparation can also be used to treat HER2-positive metastatic gastric cancer within its licensed indication.
Non-inferior to iv injection
The open-label, phase 3 HannaH trial was conducted to establish the non-inferiority of subcutaneous injection to intravenous infusion for administration of trastuzumab. A total of 596 patients with HER2-positive operable, locally advanced or inflammatory breast cancer were randomly assigned to undergo eight cycles of neoadjuvant chemotherapy in combination with trastuzumab every three weeks given by either the intravenous or subcutaneous route.
Results showed that subcutaneous trastuzumab was non-inferior to intravenous trastuzumab, with comparable serum trough concentrations (measured at predose cycle 8 before surgery) and pathological complete response rates (45.4% and 40.7%, respectively).
Further Information: Roche