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Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer's Ibrance

Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer's Ibrance
From Reuters - March 14, 2017

ZURICH Novartis has won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer's Ibrance.

The Swiss company has priced Kisqali to be cheaper than Ibrance, which analysts said could help it win business, though Kisqali's approval includes additional patient monitoring requirements that could work against the new drug.

Novartis considers Kisqali to be one of its stable of 13 new medicines with blockbuster potential for annual revenue in the billions of dollars. Analysts see global annual sales reaching $1.5 billion by 2022, Thomson Reuters data shows.

British biotech company Astex Pharmaceuticals, now part of Otsuka, will receive undisclosed payments from Novartis, having worked out the structure of the key protein targeted by Kisqali.

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 late on Monday.

The quick U.S. approval provides Novartis with the jump-off point to challenge Pfizer's Ibrance in the initial treatment of patients.

Ibrance hit about $2.1 billion in sales in 2016.

Novartis estimates that it has priced Kisqali at an 18-20 percent discount to Ibrance while providing for flexible dosing.

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