Novartis to Request Kisqali’s Approval to Treat Premenopausal Women on Basis of Phase 3 Trial

Novartis to Request Kisqali’s Approval to Treat Premenopausal Women on Basis of Phase 3 Trial
Novartis plans to begin work with regulatory authorities to request that Kisqali (ribociclib) be approved as a first-line treatment for premenopausal women with HR-positive, HER2-negative advanced breast cancer. This decision came after a Phase 3 trial demonstrated that Kisqali, in combination with hormone treatment, delayed disease progression or death in these women, compared to hormone treatment alone — allowing the trial to meet its primary goal. The company will present data from the trial — which adds to the already extensive Phase 3 data on Kisqali — at the upcoming San Antonio Breast Cancer Symposium (SABCS) in December. "There remains a significant unmet treatment need in younger women diagnosed with premenopausal advanced breast cancer, as the disease tends to be more aggressive with a poorer prognosis," Samit Hirawat, executive vice president and head of Global Drug Development at Novartis Oncology, said in a press release. Kisqali was tested in combination with various oral or injection hormone therapies in the Phase 3 MONALEESA-7 trial (NCT02278120), which included more than 670 women ages 25 to 58. All had advanced or metastatic breast cancer that produced the hormone receptor (HR), but not the human epidermal growth factor receptor-2 (HER2). They were randomly assigned to treatment with either a Kisqali combination or hormonal treatment alone. While Novartis said the treatment prolonged survival without the cancer progressing, it is withholding details for its S
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