NDAORALTABLET
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
FEMARA (letrozole) by Novartis is aromatase inhibitors [moa]. First approved in 1997.
Drug data last refreshed 20m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FEMARA (letrozole) is an oral aromatase inhibitor small molecule approved in 1997 for hormone receptor-positive breast cancer in postmenopausal women. It blocks estrogen production by inhibiting the aromatase enzyme, reducing circulating estrogen levels that fuel ER+ breast cancer growth. The drug is indicated for adjuvant and extended therapy in early-stage disease and for first-line treatment of advanced breast cancer.
$0.001BPart D
LOE ApproachingDeclining Part D spending ($1M in 2023) with heavy competitive pressure (30%) signals a mature, commoditized product with consolidating team structures.
Mechanism of Action
Aromatase Inhibitors
Pharmacologic Class:
Aromatase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
Started May 2026
1,056 enrolled
HR+/HER2- Breast Cancer
A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor
Started Jul 2025
5 enrolled
Ovarian Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Started Apr 2025
450 enrolled
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Started Jan 2025
1,035 enrolled
Breast Cancer
ALPINE: Maintenance Letrozole/Abemaciclib
Started Sep 2024
32 enrolled
Endometrial CancerRecurrent Endometrial CancerTP53
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.