Herceptin injection is a personalized medicine which is administered in two to five minutes under the skin to treat HER2-positive breast cancer.
Currently, Herceptin is given intravenously to patients and takes 30 to 90 minutes per dose.
Using Halozyme Therapeutics’ technology, Herceptin breaks down hyaluronan, gel-like substance that form a barrier between cells under the skin.
This enables the comparatively large volume of the subcutaneous formulation of Herceptin to be rapidly dispersed over a larger area.
Roche chief medical officer and Global Product Development head Hal Barron saidthat Herceptin has revolutionised the treatment of HER2-positive breast cancer over the last 14 years.
"EU approval of this subcutaneous form of Herceptin would provide a more convenient option for patients that potentially save time and healthcare resources," Barron added.
The CHMP’s positive opinion depends on the data from the phase III HannaH study, which demonstrated the efficacy and safety of the subcutaneous formulation.