FDA approves Novartis breast cancer drug, challenging Pfizer’s fast-growing Ibrance

Novartis has won U.S. food & Drug Administration approval for Kisqali to treat postmenopausal women with a difficult-to-treat form of breast cancer

approval

Novartis has won U.S. food & Drug Administration approval for Kisqali to treat postmenopausal women with a difficult-to-treat form of breast cancer, challenging Pfizer's fast-growing Ibrance

According to Novartis, "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."

"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 added.

Gabriel N. Hortobagyi, a professor of medicine at the University of Texas' MD Anderson Cancer Center and principal investigator on the Kisqali study said, "This is a significant result for women with this serious form of breast cancer."

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.

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