Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) recommended granting approval to the breast cancer drug Kisqali ...
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization ...
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 ...
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 ...
“If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who ...
Recommendation comes after recent FDA approval and positive CHMP Opinion for ribociclib (Kisqali) to help reduce the risk of recurrence in EBC. (Image Credits: Pexels) The NCCN Clinical Practice ...
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Novartis looks odds on to extend the indications of its CDK4/6 inhibitor Kisqali into early-stage breast cancer, on the back of data from the phase 3 NATALEE trial reported at the ASCO congress.
CHMP also recommended extending indications for Cerdelga (eliglustat), Hepcludex (bulevirtide), Kevzara (sarilumab), Kisqali (ribociclib), Tevimbra (tislelizumab), and Yselty (linzagolix choline).
NICE has recommended moving Novartis’ Kisqali (ribociclib) from interim funding arrangements to regular NHS reimbursement for certain previously treated breast cancer patients. In the final ...