The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday.
Novartis has reported a 28.5% reduced risk of breast cancer recurrence in an updated analysis from the Phase III NATALEE trial of Kisqali (ribociclib), when combined with endocrine therapy.
Novartis said the European Medicines Agency has recommended its Kisqali cancer drug for market authorization. The drugmaker said Friday that the EMA's Committee for Medicinal Products for Human ...
Novartis' CDK4/6 inhibitor Kisqali has claimed a broad FDA approval ... Discover how AI is transforming the pharma commercial strategy. Unlock real-time insights & actions from data.
EMA's CHMP issued a positive opinion for Novartis' Kisqali for high-risk early breast cancer. Kisqali showed a 25.1% reduced risk of cancer recurrence in Phase 3 NATALEE trial. The CHMP ...
The US FDA has approved Kisqali (ribociclib) for treating early-stage breast cancer in combination with hormone therapy. It targets high-risk HR-positive, HER2-negative stage II and III patients ...