ZURICH, March 13 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 last year, this quick approval now provides the jump-off
point for the Swiss company to challenge Pfizer's Ibrance drug
in initial treatment of this patient population. Pfizer's
$10,000-per-month drug hit about $2.1 billion in sales in 2016.
A once-daily oral dose of Kisqali plus letrozole reduced the
risk of disease progression or death by 44 percent over
letrozole alone, according to results of a study released last
year. More than half of patients with measurable disease taking
the drug combination saw a tumour burden reduction of at least
30 percent, Novartis said on Monday.
"This is a significant result for women with this serious
form of breast cancer," said Gabriel N. Hortobagyi, a professor
of medicine at the University of Texas' MD Anderson Cancer
Center and principal investigator on the Kisqali study, in the
statement from Novartis.
Novartis' drug is also under review in Europe.
(Reporting by John Miller; Editing by Alison Williams)