Novartis on Monday won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women with a difficult-to-treat form of breast cancer, challenging Pfizer’s fast-growing Ibrance.
The approval for Kisqali, previously known as LEE011 and to be administered in combination with letrozole, is for first-line treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, Novartis said in a statement.
The Swiss drugmaker considers the targeted drug as among its stable of new medicines with blockbuster potential for annual revenue in the billions of dollars.
After Novartis secured the FDA’s fast-track review status late…

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