Roche’s breast cancer drug Perjeta receives CHMP backing

Roche has announced that its new breast cancer therapy Perjeta has been granted a recommendation for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the therapy for use in combination with Herceptin and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.

Specifically, the drug was recommended for an indication among patients that have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease, with positive data from the recent phase III Cleopatra study supporting the decision.

Results from the trial released earlier this month showed that Perjeta is able to deliver significant survival benefits to breast cancer sufferers.

Dr Hal Barron, Roche's chief medical officer and head of global product development, said: "Perjeta complements Herceptin in attacking HER2-positive tumours and we believe Perjeta will transform the way people with HER2-positive metastatic breast cancer are treated."

The therapy has already been approved in this specification by regulators in the US, Mexico and Switzerland.