Log in

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.

a3p-100pxhaut logo


Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb - drapeauitalie )

  group    administrators A3P
& Project Managers

letter   newsletter A3P