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Nogitecan (topotecan)
Topotecan is a topoisomerase inhibitor that prevents DNA re-ligation, causing double-strand DNA damage.
Topotecan, sold under the brand name Hycamtin, is a chemotherapeutic agent medication used to treat ovarian cancer, lung cancer, and other cancer types. It is a topoisomerase inhibitor that works by preventing DNA re-ligation, causing double-strand DNA damage. This leads to cell death, making it an effective treatment for certain types of cancer. Topotecan is a synthetic, water-soluble analog of camptothecin. It is marketed by Pfizer Inc. and has shown clinical differentiation in its ability to target topoisomerase I. The commercial significance of topotecan lies in its effectiveness in treating various types of cancer. There are no notable pipeline developments for topotecan.
At a glance
| Generic name | topotecan |
|---|---|
| Sponsor | Novartis |
| Drug class | topotecan |
| Target | ATP-binding cassette sub-family G member 2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1996 |
Mechanism of action
Topotecan works by binding to the topoisomerase I-DNA complex and preventing the enzyme from re-ligating the DNA strands. This leads to the formation of double-strand breaks in the DNA, which cannot be efficiently repaired by mammalian cells. As a result, the cells undergo apoptosis, or programmed cell death. This mechanism of action makes topotecan an effective treatment for certain types of cancer.
Approved indications
- Malignant tumor of cervix
- Malignant tumor of ovary
- Small cell carcinoma of lung
Boxed warnings
- WARNING: MYELOSUPPRESSION Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1) ] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet count greater than or equal to 100,000/mm 3 . Monitor blood cell counts. ( 2.2 , 5.1 )
Common side effects
- Neutropenia
- Leukopenia
- Anemia
- Thrombocytopenia
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Fatigue
- Pyrexia
- Pain
- Alopecia
Drug interactions
- amiodarone
- azithromycin
- bosutinib
- captopril
- carvedilol
- ciclosporin
- clarithromycin
- conivaptan
- diltiazem
- dronedarone
- erythromycin
- felodipine
Key clinical trials
- A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (PHASE3)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia (PHASE2)
- Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer (PHASE1)
- Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (PHASE1, PHASE2)
- Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs (PHASE2)
- Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery (PHASE1)
- Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nogitecan CI brief — competitive landscape report
- Nogitecan updates RSS · CI watch RSS
- Novartis portfolio CI