Topotecan
Topotecan is the long-standing second-line chemotherapy for relapsed small-cell lung cancer, and now the comparator that new drugs must beat.
Approved 1996 (IV) and 2007 (oral) for relapsed SCLC after platinum. ORR ~20%, median OS ~6-8 months; heavy myelosuppression. Control arm in DeLLphi-304 (beaten by tarlatamab) and IDeate-Lung02.
1.Enters cell as active lactone
- Route
- Intravenous or oral
- Schedule
- 1.5 mg/m² IV days 1-5 every 21 days, or 2.3 mg/m² oral days 1-5
- Dose modifications
- Frequent dose reduction for neutropenia; renal dose adjustment
- Monitoring
- Weekly blood counts
- Medicare
- Part B or Part D
Oral anticancer drug with an injectable equivalent used for the same indication, so Medicare covers the oral form under Part B (the oral anticancer drug benefit) as well as under Part D; the pharmacy bills whichever applies. IV topotecan is Part B.
- Commercial insurance
- covered on label
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · 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.
- Appraised for
- Relapsed small-cell lung cancer
- Notes
- Also recurrent cervical cancer with cisplatin (TA183, 2009). Generic.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA184 · SMC advice: topotecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1996 | Relapsed SCLC (IV) |
| US | 2007 | Relapsed SCLC (oral) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia (grade 4) | — | 70% |
| Thrombocytopenia (grade 4) | — | 27% |
| Anaemia | 90% | — |
| Diarrhoea (oral) | 30% | — |
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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Topotecan" OR ABSTRACT:"Topotecan" OR TITLE:"Hycamtin" OR ABSTRACT:"Hycamtin") 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 Topotecan, not a curated reading list.
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