FDA approves Novartis Kisqali® to reduce risk of recurrence in …
WEB2 days ago · About Kisqali ® (ribociclib) Kisqali ® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly.
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 OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB1 day 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 ...
FDA Approves Ribociclib for Early Breast Cancer Treatment With …
WEB2 days ago · The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer. ... News release; Novartis. September 17, 2024. Accessed ...
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 mg or two 200 mg tablets for 3 weeks followed by 1 ...
Latest analysis of Novartis NATALEE study shows Kisqali® …
WEBMay 31, 2024 · NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali ® (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO 5.
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 ...
Novartis Kisqali® Phase III NATALEE trial meets primary endpoint …
WEBMar 27, 2023 · Updates to the NCCN Guidelines ® for breast cancer, released in January 2023, recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI 1 5.
Kisqali Plus Hormone Therapy for Metastatic Breast Cancer
WEBJan 11, 2023 · The combination of ribociclib with a drug to block hormones (endocrine therapy) has recently become a standard treatment for postmenopausal women with hormone receptor – positive, HER2-negative metastatic …
FDA Approves Adjuvant Ribociclib Plus AI Therapy for HR+, HER2 …
WEB2 days ago · The FDA approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor (AI) for patients with hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence, including those with node-negative disease, according to an announcement from Novartis, the manufacturer of ribociclib. 1 The approval is based on data from the phase 3 NATALEE ...