Ribociclib and endocrine therapy as adjuvant ... - ASCO Publications
WEBJun 7, 2023 · To investigate whether RIB + ET also improves outcomes in early BC (EBC), the Phase III NATALEE trial (NCT03701334) evaluated adjuvant RIB + ET in a broad population of pts with stage II or III HR+/HER2− EBC at risk for recurrence, including pts with no nodal involvement (N0).
Adding Ribociclib to Hormonal Therapy Reduces Risk of Recurrence ... - ASCO
WEBAdding the targeted therapy drug ribociclib (Kisqali®) to hormonal (endocrine) therapy showed a significant improvement in invasive disease-free survival (iDFS) for people with HR-positive, HER2-negative early-stage breast cancer.
Novartis Kisqali® shows deepening benefit in new analysis, …
WEB5 days ago · Kisqali has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide, including by the U.S. FDA and the European Commission 6,7. In the U.S., Kisqali is indicated for the treatment of adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following ...
New CDK4/6i data at ASCO reinforce Novartis Kisqali® as only …
WEBJun 03, 2022. Kisqali is the only CDK4/6 inhibitor with consistent overall survival (OS) benefit seen across all three Phase III trials, with the longest median OS benefit ever reported for HR+/HER2- mBC1-10.
Latest analysis of Novartis NATALEE study shows Kisqali® …
WEBMay 31, 2024 · The latest analysis demonstrated that Kisqali ® (ribociclib) plus endocrine therapy (ET), compared to ET alone, showed an improvement in rates of invasive disease-free survival (iDFS), distant recurrence-free survival (DRFS), and distant disease-free survival (DDFS) in high-risk EBC patients with N0 disease 1,2.
Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBMar 20, 2024 · The NATALEE trial is a phase 3 trial comparing ribociclib plus endocrine therapy with endocrine therapy alone that was designed to test CDK4/6 inhibition in a broad population of patients with...
WEBBasel, May 27, 2020 — Novartis today announced a new exploratory subgroup analysis of the Phase III MONALEESA-3 and MONALEESA-7 trials, to be presented during the ASCO20 Virtual Scientific Program, reinforcing the overall survival (OS) benefit of …
ASCO: Novartis details Kisqali's adjuvant breast cancer win
WEBJun 2, 2023 · Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in patients with certain early-stage breast cancer, according to phase 3 data from...
NATALEE: Phase III study of ribociclib (RIBO) - ASCO Publications
WEBMay 26, 2019 · Methods: The phase 3 multicenter, randomized, open-label NATALEE trial will evaluate the efficacy and safety of RIBO + ET as adjuvant treatment in patients with HR+, HER2– EBC. Eligible women (any menopausal status) and men aged ≥ 18 years will be randomized to RIBO 400 mg/day (3 weeks on/1 week off) + ET or ET alone.
FDA Approves Ribociclib With an Aromatase Inhibitor in Early …
WEB3 days ago · The FDA has approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor (AI) in hormone receptor (HR)-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. This indication includes patients with node-negative disease. Data from the phase 3 NATALEE trial (NCT03701334) support …
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