ZURICH, March 13 (Reuters) - 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)