ribociclib (Kisqali)
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Indications
- in combination with letrozole or fulvestrant, prolongs progression free survival in metastatic breast cancer
* intended for postmenopausal women with estrogen receptor- positive, HER2-negative metastatic breast cancer
Dosage
Adverse effects
- neutropenia (59.5% vs 0.9% with letrozole alone)
- leukopenia (21.0% vs 4.5%).
- nausea (51.5% vs 28.5%)
- diarrhea (35.0% vs 22.1%)
- alopecia (33.2% vs 15.5%)
- vomiting (29.3% vs 15.5%)
Mechanism of action
Clinical trials
- MONALEESA-2 trial supported by Novartis
- lead author Hortobagyi disclosed relationships with Novartis, Eli Lilly, & Pfizer
- several co-investigators disclosed relationships with multiple companies that produce & market products used to treat breast cancer
More general terms
Component of
References
- ↑ Bankhead C Anti-CDK4/6 Boosts PFS in Metastatic Breast Cancer MedPage Today. Jan 3, 2017 http://www.medpagetoday.com/hematologyoncology/BreastCancer/62304
MONALEESA-2 trial was supported by Novartis
Hortobagyi GN, et al. Ribociclib + letrozole significantly extends progression-free survival in the first-line treatment of HR+/HER2- advanced breast cancer bvs letrozole alone: First results from the phase III MONALEESA-2 study. ESMO 2016. Abstract LBA1.
Hortobagyi GN, Stemmer SM, Burris HA et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27717303 Free Article - ↑ O'Shaughnessy J, Petrakova K, Sonke GS et al Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2017 Nov 21. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29164421
- ↑ 3.0 3.1 Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm - ↑ FDA News Release. July 18, 2018 FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613801.htm
- ↑ Slamon DJ, Neven P, Chia S et al Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med 2020; 382:514-524. Feb 6. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31826360 https://www.nejm.org/doi/full/10.1056/NEJMoa1911149