Roche receives CHMP backing for breast cancer drug

Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its new breast cancer therapy Kadclya.

The treatment has been endorsed for use as a single agent among adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

In a phase III study, Kadclya was shown to help extend the life expectancy of people with previously treated advanced disease to more than two and a half years, thanks to a mode of action that delivers chemotherapy directly to cancer cells.

If approved, it would become the first antibody-drug conjugate for advanced HER2-positive breast cancer available in Europe.

Dr Hal Barron, Roche's chief medical officer and head of global product development, said: "We hope that this new medicine is soon available to patients with metastatic breast cancer in Europe."

This comes after the company received UK approval last month for its product MabThera to be used in two new vasculitis indications.