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20 March 2017, 05:12 | Melissa Porter
FDA OKs Novartis' ribociclib for first-line treatment of certain type of breast cancer
The FDA has approved ribociclib (Kisqali, Novartis) in combination with the aromatase inhibitorletrozole (Femara, Novartis) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. According to the American Cancer Society, about 40 percent of USA women diagnosed with breast cancer have this type.
In the course of the four weeks, patients are also given letrozole, which can be substituted for another aromatase inhibitor, contingent on the aspects of their condition.
"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 previous year".
Kisqali, part of the drug class called kinase inhibitors, is taken daily for three weeks, followed by a one-week break. These results were monitored in comparison with patients treated only with letrozole. More than half of patients administered ribociclib plus letrozole remained alive and progression free at the time of interim analysis, therefore median PFS could not be determined. It can not be taken by women who are pregnant or breastfeeding.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
Novartis is looking to quickly ramp up Kisqali's approved indications to take the fight to Ibrance. Regulators recommend patients receive ECG monitoring before starting up treatment with Kisqali and repeat it at day 14 of the first cycle and the beginning of the second cycle. In a move likely meant to counter that disadvantage, Novartis is jumping into the market with what it says will be an 18 percent to 20 percent lower aggregate cost based on the dosing seen in the trial.
Novartissaid a pack of 21 pills of Kisqali, a four-week supply, will have a list price of $10,950 for the 600-milligram dose.
Novartis has always been a leader in developing cancer medicines. A longer-term forecast based on six analysts' models suggests worldwide sales of the therapy could reach $1.45 billion by 2022.
The drug, also known as ribociclib, hits the market as Kisqali with peak sales estimates of around $2.5 billion a year, giving the pharma giant a clear shot at a new blockbuster franchise.
Novartis is conducting additional Kisqali studies in combination with other treatments to judge its effectiveness in those groupings.
Two are late-stage studies, usually the last stage before seeking regulatory approval, and results should be available late this year or early next year, the company said. But the company said that most health issues that arose during Kisqali's trials were mild to moderate and generally managed through interrupting or reducing the dose.
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