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Letrozole tablets
Letrozole tablets, marketed by Al-Azhar University, are indicated for the adjuvant treatment of early breast cancer. The drug's key composition patent is set to expire in 2028, providing a period of market exclusivity. The primary risk is the potential increase in competition following patent expiry.
At a glance
| Generic name | Letrozole tablets |
|---|---|
| Also known as | Cabergoline, HCG, 5mg daily (2 tablets 2.5 gm), Letrozole, Femara |
| Sponsor | Al-Azhar University |
| Drug class | Aromatase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
- Adjuvant Treatment of Early Breast Cancer
- Extended Adjuvant Treatment of Early Breast Cancer
- First-Line Treatment of Advanced Breast Cancer
- Second-Line Treatment of Advanced Breast Cancer
Common side effects
- Arthralgia
- Hot flashes
- Flushing
- Asthenia
- Edema
- Headache
- Dizziness
- Hypercholesterolemia
- Increased sweating
- Bone pain
- Musculoskeletal disorders
- Fractures
Serious adverse events
- Fractures
- Myocardial infarction
- Thromboembolic events
- Endometrial hyperplasia/cancer
- Osteoporosis
Drug interactions
- Tamoxifen
- Cimetidine
- Warfarin
Key clinical trials
- A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (PHASE3)
- A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer (PHASE3)
- BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (PHASE1)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification (PHASE2, PHASE3)
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (PHASE3)
- A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |