What do oncologists think of the monarchE trial (VERZENIO®)?
monarchE — Adjuvant HR+/HER2-, node-positive, high-risk early breast cancer
FDA APPROVED · adjuvant early BCFDA-approved for adjuvant treatment of HR-positive, HER2-negative, node-positive, high-risk early breast cancer (originally October 12, 2021; expanded March 3, 2023 to remove the Ki-67 testing requirement).
Physician voices — verbatim
Full physician voice list (48)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
What do oncologists think of the MONARCH-3 trial (VERZENIO®)?
MONARCH-3 — First-line HR+/HER2- advanced/metastatic breast cancer (with an aromatase inhibitor)
FDA APPROVED · 1L metastatic BCFDA-approved February 26, 2018, in combination with an aromatase inhibitor as initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer.
Physician voices — verbatim
Full physician voice list (7)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
VERZENIO® — FDA status
FDA APPROVEDVERZENIO® (abemaciclib) is FDA-approved for hormone-receptor-positive, HER2-negative breast cancer — including adjuvant treatment of node-positive, high-risk early breast cancer and, with endocrine therapy, advanced or metastatic disease. For the full, current list of FDA indications and prescribing information, see verzenio.com or FDA label (DailyMed). KOL Pulse indexes the physician conversation; the label is owned and maintained by the manufacturer.
VERZENIO® sentiment — FAQ
monarchE
What do oncologists think of the monarchE trial (VERZENIO®)?
Across 48 verified physician voices in KOL Pulse's index for monarchE, 29% expressed positive sentiment, 27% were nuanced (praising the result while flagging a caveat), 42% were neutral, and 2% were critical. Positive voices highlight the invasive-disease-free-survival benefit of adding two years of abemaciclib to endocrine therapy, and the practice-changing move of a CDK4/6 inhibitor into the curative-intent adjuvant setting; nuanced and critical voices flag immature overall survival, two-year toxicity and discontinuation, and which patients truly need escalation versus endocrine therapy alone.
Where can I find the monarchE trial data for VERZENIO® (abemaciclib)?
monarchE is registered as NCT03155997 and studied VERZENIO® (abemaciclib) in Adjuvant HR+/HER2-, node-positive, high-risk early breast cancer. KOL Pulse's monarchE trial profile is coming soon.
MONARCH-3
What do oncologists think of the MONARCH-3 trial (VERZENIO®)?
Across 7 verified physician voices in KOL Pulse's index for MONARCH-3, 14% expressed positive sentiment, 43% were nuanced (praising the result while flagging a caveat), 29% were neutral, and 14% were critical. Positive voices highlight the progression-free-survival benefit of adding abemaciclib to a first-line aromatase inhibitor in HR+/HER2- metastatic breast cancer; nuanced and critical voices flag overall-survival maturity, gastrointestinal toxicity, and how CDK4/6 inhibitors sequence and compare within the class.
Where can I find the MONARCH-3 trial data for VERZENIO® (abemaciclib)?
MONARCH-3 is registered as NCT02246621 and studied VERZENIO® (abemaciclib) in First-line HR+/HER2- advanced/metastatic breast cancer (with an aromatase inhibitor). KOL Pulse's MONARCH-3 trial profile is coming soon.
Regulatory
Is VERZENIO® (abemaciclib) FDA approved?
VERZENIO® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.