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Novartis, Kisqali
Novartis’ Kisqali cleared for expanded indication by FDA
The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,
Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer
An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.
FDA expands Novartis’ Kisqali label to include early breast cancer patients
Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.
FDA Approves Kisqali Regimen for HR+/HER2- Early Breast Cancer
Kisqali has been FDA-approved with an aromatase inhibitor as postsurgical treatment for some with early breast cancer at a high risk of recurrence.
FDA expands use of Kisqali to early stage breast cancer patients
Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.
FDA Expands Approval of Ribociclib to Early Breast Cancer
The drug joins abemaciclib (Verzenio) as approved CDK4/6 inhibitors in this setting, but the broader indication for ribociclib -- which includes node-negative (N0) disease -- roughly doubles the population of early breast cancer patients eligible for adjuvant therapy with a CDK4/6 inhibitor, according to drugmaker Novartis.
FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
Unlike rival CDK 4/6 inhibitor abemaciclib, patients don't need to be lymph-node positive to receive ribociclib after surgery.
Kisqali wins FDA nod for breast cancer treatment: Dosage, effectiveness and side effects of the breakthrough drug
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 ...
Novartis’ Kisqali receives FDA approval to reduce the risk of breast cancer recurrence
Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive,
pharmaphorum
4d
Lilly on alert as new Kisqali approval threatens Verzenio
Verzenio was approved for a similar adjuvant indication last year, having been used for a couple of years only in patients ...
Zacks.com on MSN
2d
Pharma Stock Roundup: FDA Approvals for LLY, MRK, AZN & JNJ Drugs
This week, the FDA approved Eli Lilly’s LLY eczema drug, Ebglyss (lebrikizumab), and the expanded use of Novartis’ NVS ...
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