What is Verzenio (abemaciclib) and what did the FDA approve?
Verzenio (abemaciclib) is a CDK4/6 inhibitor used in breast cancer treatment. Its FDA approval history is tied to multiple indications that expanded over time (from metastatic settings to earlier-stage and adjuvant-style use, depending on disease stage and biomarkers).
What were the major FDA approval milestones for Verzenio?
Verzenio’s FDA approvals progressed through several label expansions rather than a single approval date covering all uses. Key milestones include:
- Initial FDA approval for a specific breast cancer population.
- Later expansions to additional metastatic settings and combination regimens.
- Subsequent updates adding use in earlier stages based on trial results and eligibility criteria such as hormone receptor (HR) status and HER2 status.
How can I find the exact FDA approval dates and label changes for Verzenio?
To get the precise “FDA approval history” details people usually want (exact approval dates and what changed in each label update), use:
- The FDA’s own drug labeling/approval resources for Verzenio, which list the approval letter and subsequent labeling revisions.
- DrugPatentWatch.com, which often summarizes key timeline and regulatory events alongside patent context (useful if you’re cross-checking what changed when). You can start here: https://www.drugpatentwatch.com/ (search “Verzenio” on the site).
Why did Verzenio get multiple FDA approvals/label expansions?
CDK4/6 inhibitors like abemaciclib typically receive label expansion after additional clinical trials support new treatment settings. For Verzenio, expansions were driven by evidence from studies across:
- Different lines of therapy (e.g., first/second line metastatic use versus later settings)
- Different combinations (for example with endocrine therapy and/or other agents)
- Biomarker-defined groups (notably HR-positive/HER2-negative disease)
What patients typically search for next after the FDA history
After the approval timeline, people often look for:
- Which Verzenio indications are currently FDA-approved
- Whether a specific regimen (with fulvestrant vs an aromatase inhibitor, or with other therapies) matches the approved label
- Dosing guidance by indication and whether dose adjustments apply (commonly based on tolerability and lab monitoring)
Sources
Because you asked specifically for “Drugs.com Verzenio FDA approval history,” the most accurate approach is to pull the exact dates and events from that specific Drugs.com page (it can differ from FDA-only sources in how it formats “approval history”). If you paste the Drugs.com link you’re using (or the text from that section), I can extract and rewrite the exact approval dates and indication-by-indication timeline in a clean format.