FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB6 days ago · Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2 ...
FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer
WEB5 days ago · "The FDA approval of [ribociclib] for this early breast cancer population, including those with N0 disease, is a pivotal moment in improving our approach to care," Dennis J. Slamon, MD, director ...
FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB4 days ago · The new indication joins ribociclib's previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.
Ribociclib Combo Approved in HR+/HER2- Stage II-III Early Breast Cancer
WEB6 days ago · The FDA has approved ribociclib (Kisqali) plus an aromatase inhibitor as adjuvant treatment for patients with hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence, according to a press release from Novartis. 1 The dosing information included a once daily oral dose of ribociclib at 400 mg or two 200 mg tablets for 3 weeks followed by 1 ...
FDA Approves Adjuvant Ribociclib (Kisqali) Plus an Aromatase …
WEB5 days ago · FDA officials based their decision on results from the open-label, multicenter, phase 3 NATALEE clinical trial.The study included 5,101 adults with HR-positive, HER2-negative early breast cancer with lymph node involvement, tumors larger than 5 cm, or tumors 2–5 cm in size with either grade 2 or grade 3 disease.. Patients were randomly assigned in a 1:1 manner to receive either ribociclib at ...
FDA Approves Ribociclib With an Aromatase Inhibitor in Early Breast Cancer
WEB5 days ago · "The FDA approval of [ribociclib] for this early breast cancer population, including those with [node-negative] disease, is a pivotal moment in improving our approach to care," Dennis J. Slamon, MD, director of clinical/translational research, UCLA Jonsson Comprehensive Cancer Center and chairman of the Board of Translational Research In Oncology and NATALEE trial lead investigator, said in a ...
Ribociclib Improves Survival in Advanced Breast Cancer
WEBOct 6, 2021 · Women with metastatic breast cancer treated with ribociclib (Kisqali) and letrozole (Femara) as their initial treatment lived approximately 1 year longer overall than women treated with letrozole only, updated results from the MONALEESA-2 …
Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBMar 20, 2024 · Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast...
Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as …
WEBApr 11, 2024 · The study demonstrates the effectiveness and safety of ribociclib in a real-world setting of Brazilian patients with HR+/HER2– advanced breast cancer with a higher rate of PFS at 12 months than in the MONALEESA-2 9-11 and MONALEESA-7 12 trials (77.6%, 74.53%, and 72.7%, respectively).
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
WEBMar 9, 2022 · First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced...
- Some results have been removed
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