FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB23 hours 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 approval of new drug regimen helps reduce risk of breast cancer ...
WEB3 days ago · These findings of the NATALEE clinical trial ultimately led to the FDA approving ribociclib in combination with hormonal therapy for the adjuvant treatment of HR-positive, HER2-negative early-stage breast cancer. It was approved on Sept. 17.
Ribociclib Combo Approved in HR+/HER2- Stage II-III Early Breast Cancer
WEB3 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 ...
FDA Approves Ribociclib for Early Breast Cancer Treatment With …
WEB2 days ago · Ribociclib is manufactured by Novartis for early breast cancer and advanced or metastatic breast cancer. 2 The approval was supported by the NATALEE (NCT03701334) trial, a randomized, open-label ...
FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer
WEB2 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 Yields Extended iDFS Benefit in HR+/HER2– Breast Cancer
WEB4 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 ...
Ribociclib Improves Survival in Advanced Breast Cancer
WEBOct 6, 2021 · A large study found that ribociclib and letrozole improved overall survival in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. This combination is the standard first-line treatment, but other CDK4/6 inhibitors may have different side effects and benefits.
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...