Topotecan
Also known as: Hycamtin · Topotecan Hospira · Potactasol
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, topotecan monotherapy is indicated for the treatment of adult patients with relapsed small cell lung cancer for whom re-treatment with the first-line regimen is not considered appropriate, and topotecan is also indicated for treating patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. In the United States, topotecan injection is indicated as a monotherapy for small cell lung cancer sensitive disease after failure of first-line chemotherapy. Additionally, topotecan in combination with cisplatin is indicated in both the European Union and the United States for treating patients with stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative surgery or radiotherapy.
From: Source: European Medicines Agency (EMA), Hycamtin — EPAR, 20/01/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Topotecan Hospira — EPAR, 31/03/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 57308 topotecan
- EMA
- EMEA/H/C/000123, EMEA/H/C/001192, EMEA/H/C/002282
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Hycamtin
Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
Source: European Medicines Agency (EMA), Hycamtin — EPAR, 20/01/2026. © European Medicines Agency.
Document date: 20/01/2026 · Official document →
FDA (USA) Topotecan
1 INDICATIONS AND USAGE Topotecan Injection is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies ( 14 ) ] . Topotecan Injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. Topotecan is a topoisomerase inhibitor indicated for: small cell lung cancer sensitive disease after failure of first-line chemotherapy. ( 1 ) combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. ( 1 )
Data provided by the U.S. Food and Drug Administration.
Document date: 20251217 · Official document →
EMA (EU) Topotecan Hospira
Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.
Source: European Medicines Agency (EMA), Topotecan Hospira — EPAR, 31/03/2026. © European Medicines Agency.
Document date: 31/03/2026 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Topotecan approved for in the European Union?
Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. (Source: European Medicines Agency (EMA), Hycamtin — EPAR, 20/01/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Hycamtin — EPAR, 20/01/2026. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Topotecan Hospira — EPAR, 31/03/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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