Roche announced that it has received approval from European regulators for its perjeta drug to help treat breast cancer.
The approval comes from the European Medicines Agency and covers patients with previously untreated HER2-positive metastatic breast cancer. The drug is approved in combination with two other treatments - Herceptin and docetaxel - in adult patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
The European approval comes after a late-stage trial showed that the combination of perjeta, Herceptin and chemotherapy provided patients with a median of 6.1 months longer without their disease worsening. It also provided a 34 percent reduction in the risk of death compared to Herceptin and chemotherapy alone.
The company said that perjeta is now approved in the EU, the U.S., and Switzerland for the treatment of people with this form of breast cancer. Further country approvals are anticipated during 2013.
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