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meRfi® Microbiome - The Digital Gut Microbiome Reference (incl. AI Chat)
Prebiotics, Probiotics, FMT / Manipulators of the Intestinal Microbiota

AuthorsReferences (Sources)

AuthorsReferences (Sources)

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Letrozole + Ribociclib & Breast cancer / Mammacarcinoma (HR+) (Her2-)

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Approval status

The FDA has approved ribociclib (Kisqali TM) for various breast cancer treatments over the years:

March 13, 2017: Ribociclib was approved in combination with an aromatase inhibitor for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

May 8, 2017: The FDA approved the ribociclib/letrozole co-pack (Kisqali Femara Co-Pack) for the same condition.

September 17, 2024: Ribociclib, in combination with an aromatase inhibitor, received approval for adjuvant treatment. This includes the ribociclib + letrozole co-pack for adults with HR-positive, HER2-negative stage II–III early breast cancer at high risk of re…

References (Sources)

First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results
O'Shaughnessy et al. 2019 JCO 37: 1078-1078
Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2
Verma et al. 2018 Breast Cancer Res Treat 170(3): 535-545
Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration
Hilal et al. 2020 JAMA Intern. Med. 180: 1108
Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer
Jhaveri et al. 2023 Ther Adv Med Oncol 15: 17588359231216095
Optimizing hormone therapy for breast cancer: Translating gains to the early-stage setting
Chien et al. 2022 Cell Rep Med 3(6):100664
Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial
Prat et al. 2020
Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer
Burris et al. 2021 Br J Cancer 125(5): 679-686

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7/1/2026

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Links

https://ascopost.com/News/55617)
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ribociclib-aromatase-inhibitor-and-ribociclib-and-letrozole-co-pack-early-high-risk)
https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali)