Trastuzumab Approved for HER2 Gastric Cancer in Europe

MedScape reports Trastuzumab Approved for HER2 Gastric Cancer in Europe:

Trastuzumab (Herceptin, Roche) has been approved for use in the treatment of HER2-positive gastric cancer by the European Commission.  This is the first approval in the world for this label extension for trastuzumab, which is already marketed for use in the treatment of HER2-positive breast cancer.

This marketing authorization is effective immediately in all European Union countries, and in Iceland, Liechtenstein, and Norway, according to the manufacturer.  Similar approvals for this label extension in other regions of the world are expected to follow soon, says Roche.

Approval for this new indication is based on the results of the international ToGA trial, headed by Eric van Cutsem, MD, PhD, from University Hospital Gasthuisberg in Leuven, Belgium.  The results showed that trastuzumab added to chemotherapy significantly prolonged survival — from a median of 11.8 months with chemotherapy alone to a median of 16 months.

When the results from the ToGA trial were first reported at last year's annual meeting of the American Society of Clinical Oncology (ASCO), data were hailed as "practice-changing."  ASCO later listed the study as one of the major advances in cancer in 2009.

Wow, this is great, sounds like an important new treatment option for gastric cancer, which is the second most common cause of cancer-related death in the world, and is the fourth most commonly diagnosed cancer with more than 1,000,000 cases diagnosed each year.