Company plans to file marketing application in other countries in the near future.
The European Commission approved Roche’s Herceptin in combination with chemotherapy for the treatment of patients with HER2-positive metastatic stomach cancer. The label-extension submission was reviewed through an accelerated process by the European authorities on the back of positive results from the 594-patient international ToGA trial.
The ToGA data confirmed a significant survival benefit of adding Herceptin to chemotherapy. The overall survival of patients with HER2-positive metastatic gastric cancer increased from 11.8 months when treated using chemotherapy alone to 16 months when given Herceptin as well.
Roche said it plans to submit for approval of Herceptin as a treatment for stomach cancer in other countries in the near future. In June 2009, the labeling of two HER2 testing products used to predict treatment response to Herceptin in breast cancer was expanded to include analytical claims for use with gastric tissue samples.
Sales of Herceptin for HER2-positive breast cancer reached CHF 2.6 billion (about $2.47 billion) in the first half of 2009, up 10% in local currencies on the same period in 2008. The drug was Roche’s third best-selling pharmaceutical in the first half of last year, behind the anticancer drugs MabThera/Rituxan and Avastin.
Roche is also studying a subcutaneous formulation of Herceptin in Phase III trials and recently invested CHF 190 million (over $181 million) on two European manufacturing facilities to develop a patient-friendly device that would allow the subcutaneous self-administration of its biological anticancer drugs.