receives EU approval for breast cancer drug Kisqali
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[August 24, 2017] ZURICH
(Reuters) - Novartis AG said its drug Kisqali (ribociclib) received
European Union approval as first-line treatment for a tough-to-treat
breast cancer, bolstering the Swiss drugmaker's bid to challenge U.S.
rival Pfizer's Ibrance.
The EU approved Kisqali in combination with an aromatase inhibitor,
such as letrozole, for treatment of postmenopausal women with
hormone receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) locally advanced or metastatic breast cancer as
initial endocrine-based therapy, Novartis said.
The announcement, while expected, underscores Novartis's push to
strengthen an oncology portfolio hurt last year by the patent
expiration on blood cancer drug Glivec.
Novartis considers Kisqali to be one of its new medicines with
blockbuster potential for annual revenue in the billions of dollars.
Pfizer's rival drug Ibrance hit about $2.1 billion in sales in 2016.
The approval is based on pivotal phase III MONALEESA-2 trial, which
showed Kisqali plus letrozole reduced risk of disease progression or
death by 43 percent versus letrozole alone.
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It follows a positive opinion granted in June by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) and the green light from the U.S. Food and Drug
administration (FDA) in March.
(Reporting by Silke Koltrowitz)
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