FDA expands approval of breast cancer drug Kisqali
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- 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 recurrence12. The approval allows treatment with a CDK4/6 inhibitor to a broader group of people, minimizing their risk of cancer returning3. In a clinical trial, women treated with ribociclib and letrozole lived approximately 1 year longer overall than women treated with letrozole alone4.Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.www.fda.gov/drugs/resources-information-approve…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. 1www.cancernetwork.com/view/ribociclib-combo-ap…
"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 news release.2 "Today's approval...
www.targetedonc.com/view/fda-approves-ribocicli…In the clinical trial, called MONALEESA-2, women treated with the CDK4/6 inhibitor ribociclib (Kisqali) and the hormone-blocking drug letrozole (Femara) as their initial treatment for advanced breast cancer lived approximately 1 year longer overall than women treated with letrozole alone.www.cancer.gov/news-events/cancer-currents-blog… FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB5 days ago · Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in …
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," …
FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
WEB3 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 …
Ribociclib Combo Approved in HR+/HER2- Stage II-III Early Breast …
WEB5 days ago · The FDA has approved ribociclib (Kisqali) plus an aromatase inhibitor as adjuvant treatment for patients with hormone receptor (HR)–positive, HER2-negative …
FDA Approves Ribociclib for Early Breast Cancer Treatment With …
WEB4 days ago · The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer.
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...
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 …
Real-World Evidence of Ribociclib Plus Aromatase …
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 …
Overall Survival with Ribociclib plus Letrozole in …
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...
Ribociclib and endocrine therapy as adjuvant treatment in patients …
WEBJun 7, 2023 · Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial. | …
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