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Novartis: CHMP approves breast cancer drug

Swiss pharmaceutical giant Novartis on Friday received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP), a body of the European Union, for its new drug called Kisqali, against breast cancer.

The CHMP expressed support for this new treatment, used in combination with an aromatase inhibitor, for postmenopausal women with advanced or metastatic breast cancer, the Basel group said in a statement.

This committee, which is responsible for examining drugs that can be marketed in the European Union, has relied on the results of a Phase III study, Monaleesa-2.

Clinical trials showed that the risk of disease progression or death decreased by 44% in women treated with Kisqali in addition to letrozole anti-aromatase, compared with letrozole alone.

Anti-aromatases, used in hormone therapy for breast cancer in postmenopausal women, are a class of drugs that act on an enzyme, aromatase, to act on estrogens.

The new drug has already been approved in the US in March, with Novartis reporting that further claims are also pending.

The European Commission generally aligns itself with the opinions of the CHMP within a period of two months.

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