FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB2 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.
FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB4 days ago · On September 17, 2024, the FDA approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor and ribociclib and letrozole co-pack (Kisqali Femara Co-Pack ...
FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer
WEB4 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 ...
Ribociclib Combo Approved in HR+/HER2- Stage II-III Early Breast Cancer
WEB4 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 ...
Ribociclib Combo Yields Extended iDFS Benefit in HR+/HER2– Breast Cancer
WEB5 days ago · Combining ribociclib (Kisqali) with nonsteroidal aromatase inhibitor (NSAI) therapy demonstrated sustained improvements in invasive disease-free survival (iDFS) and distant disease-free survival (DDFS) vs NSAI alone among patients with hormone receptor (HR)–positive, HER2-negative early breast cancer, according to 4-year landmark analysis data from the phase 3 NATALEE trial (NCT03701334 ...
NATALEE Trial Long-Term Results on Ribociclib Combination …
WEBJan 25, 2024 · Invasive disease–free survival continued to be significantly improved for patients with hormone receptor–positive, HER2-negative, early-stage breast cancer who received the CDK4/6 inhibitor ribociclib plus a nonsteroidal aromatase inhibitor compared with a nonsteroidal aromatase inhibitor alone.
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...
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...
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).