EXEMESTANE

Post-LOE

Alvogen

ANDAORALTABLET

Approved

Jul 2014

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

EXEMESTANE by Alvogen is estrogen-dependent. Approved for advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see ]. First approved in 2014.

Drug data last refreshed 20h ago

$0.0BPart D

Mechanism of Action

estrogen-dependent. Aromatase is the principal enzyme that converts androgens to estrogens both in pre- and postmenopausal women. While the main source of estrogen (primarily estradiol) is the ovary in premenopausal women, the principal source of circulating estrogens in postmenopausal women is…

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT03659136Phase 2Completed

The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

Started Nov 2018

103 enrolled

Breast Neoplasms

NCT03137368Phase 3Unknown

A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

Started Aug 2018

300 enrolled

CYP2D6 Polymorphism

NCT03538171Phase 3Unknown

Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

Started May 2018

375 enrolled

Advanced Breast Cancer

NCT03312738Phase 2Completed

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

Started Sep 2017

159 enrolled

Advanced Breast Cancer

NCT02990845Phase 1/2Terminated

Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer

Started Sep 2017

16 enrolled

Premenopausal Breast Cancer

Worked on EXEMESTANE at Alvogen? Share your interview experience or compensation data (+7 days Pro)

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.