Patients with gastric cancer in the UK have been given access to a new treatment option following the extended approval of Swiss drugmaker Roche’s biologic Herceptin.
Specifically, regulators have issued a green light for Herceptin (trastuzumab) to treat patients with HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction with standard chemotherapy, but only in those who have not received any previous therapy for their metastatic disease.
The move comes on the back of results from a Phase III clinical trial showing that the drug, when given alongside chemotherapy, can significantly increase the lives of patients with HER2-positive gastric tumours, from 11.8 months to 16 months compared to those receiving chemotherapy alone.
Gastric cancer is a particularly aggressive form of the disease and is associated with a poor prognosis and low survival rates. There are currently few treatment options for patients with gastric cancer, and so the approval of a new therapy with the potential to significantly extend life will be welcomed those with HER2-positive tumours (around one in six of patients).
Herceptin, which was first launched for breast cancer in 2006, is a targeted anti-cancer therapy that works by blocking tumour growth, and according to Dr Mark Harrison, consultant oncologist at the Mount Vernon Cancer Centre in London, is “the first ever biological drug that is effective against HER2-positive metastatic gastric cancer and represents a major clinical advance in the treatment of these patients”.
Andrew Wilson-Webb, Chief Executive of the Rarer Cancers Forum agreed: “There are around 8,000 new cases of gastric cancer diagnosed in the UK each year [and] the approval of trastuzumab, combined with chemotherapy, represents a significant advance in how patients with this type of metastatic gastric cancer are treated”.
However, all eyes will now be on whether the drug gets past National Health Service cost watchdog the National Institute for Health and Clinical Excellence, which is due to assess the drug’s value-for-money as a treatment for HER2-positive metastatic gastric cancer sometime in 2010, with guidance anticipated by the end of the year.
The Institute has recommended the use of Herceptin in patients with HER2-positive early stage breast cancer on the NHS, on the basis that, despite a price tag of about £20,000 per patient per year, the drug is able to extend progression-free life for a number of years.
