FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB21 hours ago · Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28 ...
Kisqali Approved for HR+, HER2- Early Breast Cancer
WEB1 day ago · At 36 months, the iDFS rate was 90.7% in the ribociclib arm and 87.6% in the control arm (hazard ratio [HR], 0.749; 95% CI, 0.628, 0.892). Overall survival data were immature at the final iDFS ...
FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer
WEB2 days ago · The FDA has approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor (AI) for the treatment of patients with hormone receptor–positive, HER2-negative stage II and III early breast ...
Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBMar 20, 2024 · The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals. Conclusions. Ribociclib plus an NSAI significantly improved invasive...
Ribociclib Plus AI Greenlighted for High-Risk Breast Cancer
WEB2 days ago · The FDA approved ribocilib (Kisqali; Novartis) with an aromatase inhibitor (AI) for breast cancer patients with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The agency also approved Novartis’s Kisqali Femara Co-Pack, which includes both ribociclib and the company’s AI, letrozole (Femara), for the same indication. In a phase III, open-label ...
Ribociclib Combo Yields Extended iDFS Benefit in HR+/HER2– …
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 ...
FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB3 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 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 ...
Ribociclib Combo Approved in HR+/HER2- Stage II-III Early Breast …
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 ...
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 …