The approval is based on the positive results from the international ToGA trial, which showed that treatment with Herceptin prolongs the lives of patients with this aggressive cancer. Overall survival for patients with high levels of HER2 in the ToGA study was 16 months, versus 11.8 months (on average) for patients receiving chemotherapy alone.
Based on the results from the phase III ToGA study, the submission for the label extension was reviewed in an accelerated process by the European Health Authorities, allowing patients to benefit from the treatment. The marketing authorisation is valid with immediate effect in all the EU and EEA-EFTA states (Iceland, Liechtenstein and Norway).
Following approval in the EU, approvals for a label extension for Herceptin in other regions of the world are expected to follow soon.
Pascal Soriot, chief operating officer of pharmaceutical division at Roche, said: “Herceptin is the first targeted biological therapy to show a survival benefit in advanced stomach cancer and represents a significant advance in the treatment of this devastating disease. We believe that Herceptin will help patients with HER2-positive stomach cancer, as much as it has helped so many women with HER2-positive breast cancer.”
Eric Van Cutsem, professor at University Hospital Gasthuisberg in Leuven, Belgium, and one of the lead investigators of the ToGA trial, said: “I am delighted that today’s approval will make Herceptin available to patients with HER-2 positive metastatic stomach cancer across Europe. The approval of Herceptin for HER2-positive stomach cancer represents an important advance for the treatment of these patients. Clinicians will need to ensure that patients with metastatic stomach cancer are accurately tested for HER2 expression.”