OnCo
drugsProductApproved1997🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Letrozole (and other aromatase inhibitors)

Daily pills that stop the body making oestrogen after menopause, the backbone of hormone therapy for most breast cancers.

Non-steroidal (letrozole, anastrozole) and steroidal (exemestane) aromatase inhibitors block conversion of androgens to oestrogens in fat and tumour tissue. Superior to tamoxifen for postmenopausal women in adjuvant (ATAC, BIG 1-98) and metastatic settings; the standard partner for CDK4/6 inhibitors in first-line metastatic disease. Used with ovarian suppression in premenopausal women (SOFT/TEXT). Arthralgia, bone loss, and vaginal dryness drive non-adherence.

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Letrozole
PubChem
Mechanism, step by step
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1.Adrenal androgens circulate to fat, muscle, and tumour

Modality
Small-molecule aromatase inhibitor
Mechanism
Competitive (letrozole, anastrozole) or irreversible (exemestane) inhibition of CYP19A1 aromatase.
Brand / code
Femara; anastrozole (Arimidex); exemestane (Aromasin)
Dosing & schedule
Route
Oral
Schedule
Letrozole 2.5 mg, anastrozole 1 mg, or exemestane 25 mg once daily; 5-10 years adjuvant; until progression metastatic
Dose modifications
Rarely needed; switch agent for intolerable arthralgia
Monitoring
Bone density every 1-2 years; lipids

Source: www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf. Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Letrozole, anastrozole and exemestane are all generic, low-tier Part D drugs.

Commercial insurance
covered on label

Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA112 · 2006SMC: accepted
Appraised for
Adjuvant hormonal therapy for early oestrogen-receptor-positive breast cancer
Notes
Anastrozole, letrozole and exemestane are all generic; NICE NG101 governs use. Anastrozole was licensed for breast cancer prevention in 2023 under the MHRA repurposing programme.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA112 · SMC advice: letrozole and other aromatase inhibitors. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 25 Jul 1997ApprovalUS

    Letrozole approved for advanced breast cancer

  2. 28 Dec 2005ApprovalUS

    Letrozole adjuvant indication

Approvals

RegionYearIndication
US1997Advanced breast cancer after tamoxifen (letrozole)
US2005Adjuvant early breast cancer (letrozole)
US1997Advanced breast cancer in postmenopausal women; adjuvant from 2005

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Arthralgia/myalgia
35%
Hot flushes
33%
Bone fracture (5-year)
10%
Fatigue
20%
Arthralgia
25%
Bone loss / fracture

Cumulative; DEXA monitoring recommended. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
575 studies21 recruiting72 Phase 232 Phase 3
Search “Letrozole” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Letrozole (and other aromatase inhibitors)
intervention: Letrozole
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend240 papers in the last 12 months+2% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Letrozole" OR ABSTRACT:"Letrozole" OR TITLE:"and other aromatase inhibitors" OR ABSTRACT:"and other aromatase inhibitors" OR TITLE:"Femara; anastrozole" OR ABSTRACT:"Femara; anastrozole" OR TITLE:"Arimidex ; exemestane" OR ABSTRACT:"Arimidex ; exemestane" OR TITLE:"Aromasin" OR ABSTRACT:"Aromasin") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Letrozole (and other aromatase inhibitors), not a curated reading list.

Connected

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