An easily injectable formulation of Roche’s breast cancer drug Herceptin has been shown to be as safe and effective as the intravenous version now available.
The new version of Herceptin (trastuzumab), available via subcutaneous (SC) injection, reduces the drug’s administration time from 30 to five minutes.
UK patients who are eligible for the SC formulation could be treated more rapidly, freeing up capacity in hospital chemotherapy facilities.
The HannaH trial compared Herceptin SC with Herceptin IV in 596 women with untreated HER2-positive early-stage breast cancer.
The study met its primary endpoint of ‘non-inferiority’ for pharmacokinetics and success in tumour eradication, and there were no new safety concerns.
Breast cancer is the most common cancer in the UK, with more than 48,000 newly diagnosed patients and 12,000 fatalities in 2008.
Herceptin is a targeted drug that blocks the function of HER2, a protein produced by a gene with cancer-causing potential. It uses the body’s immune system to destroy the tumour cells.
In 15% of women with breast cancer, increased quantities of the HER2 receptor are present on the tumour cells. HER2-positive breast cancer is associated with relatively poor survival rates.
Herceptin is indicated in Europe for the treatment of early-stage and metastatic breast cancer and metastatic gastric cancer. It is currently approved in an IV formulation only.
Herceptin SC uses a specialised technology to break down the skin barrier to drugs, enabling the subcutaneous injection of large volumes of medication.
Dr Mark Verrill, Consultant Medical Oncologist at Freeman Hospital, Newcastle Upon Tyne, commented: “The result of the HannaH trial is good news, particularly for patients. Herceptin is the standard of care, so the ability to deliver the drug in approximately five minutes without the need to secure intravenous access makes the treatment far more convenient.
“Aside from the benefit for patients, Herceptin SC has the potential to ease capacity at busy chemotherapy day units and may facilitate treatment close to home, resonating with the Cancer Reform Strategy.”
Roche is the world’s largest biotechnology firm, specialising in the development of personalised medicines for oncology, virology, inflammation, metabolism and CNS disorders.