Yahoo Finance : declared in Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

The American Cancer Society estimates more than 250,000 women will be diagnosed with invasive breast cancer in 2017[3]. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease. Kisqali® (ribociclib) Important Safety InformationKisqali® (ribociclib) can cause a heart problem known as QT prolongation. "Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer," said Bruno Strigini, CEO, Novartis Oncology. Before taking Kisqali, patients should tell their healthcare provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby.

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

FDA approves Novartis breast Cancer addiction, challenging Pfizer's fast-growing IbranceNovartis has won U.S. food & Drug Administration approval for Kisqali to treat postmenopausal women with a difficult-to-treat form of breast cancerNovartis 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 IbranceAccording 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." Pfizer's $10,000-per-month drug hit about $2.1 billion in sales in 2016. 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.


ZURICH Novartis has won U.S. Food and addiction 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 quick U.S. approval provides Novartis with the jump-off point to challenge Pfizer's Ibrance in the initial treatment of patients. "Physicians will likely find the monitoring requirements associated with Kisqali to be burdensome relative to Ibrance," Fernandez wrote. Novartis said that no head-to-head studies of Kisqali and Ibrance had been done, making efficacy and safety comparisons impossible. Novartis estimates that it has priced Kisqali at an 18-20 percent discount to Ibrance while providing for flexible dosing.



collected by :Lucy William

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