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DACARBAZINE
DACARBAZINE is a Alkylating Drug [EPC] drug. It is currently FDA-approved (first approved 1975) for Metastatic Malignant Melanoma, Hodgkin's Disease.
Dacarbazine is a marketed chemotherapy agent primarily indicated for metastatic malignant melanoma, holding a significant position in this therapeutic area. Its key strength lies in its established use and the extended market exclusivity until the key composition patent expires in 2028. The primary risk is the lack of revenue data, which may affect investment decisions and strategic planning.
At a glance
| Generic name | DACARBAZINE |
|---|---|
| Drug class | Alkylating Drug [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1975 |
Approved indications
- Metastatic Malignant Melanoma
- Hodgkin's Disease
Boxed warnings
- WARNING It is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 1.Hemopoietic depression is the most common toxicity with dacarbazine (see WARNINGS ). 2.Hepatic necrosis has been reported (see WARNINGS ). 3.Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. 4.In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity. Boxed Warning WARNING It is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Hemopoietic depression is the most common toxicity with dacarbazine (see WARNINGS ). Hepatic necrosis has been reported (see WARNINGS ). Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
Common side effects
- anorexia, nausea, and vomiting
Key clinical trials
- Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas (PHASE1)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment (PHASE1, PHASE2)
- Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (PHASE2, PHASE3)
- Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (PHASE3)
- Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness (PHASE1, PHASE2)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DACARBAZINE CI brief — competitive landscape report
- DACARBAZINE updates RSS · CI watch RSS
Frequently asked questions about DACARBAZINE
What is DACARBAZINE?
What is DACARBAZINE used for?
What drug class is DACARBAZINE in?
When was DACARBAZINE approved?
What development phase is DACARBAZINE in?
What are the side effects of DACARBAZINE?
Related
- Drug class: All Alkylating Drug [EPC] drugs
- Indication: Drugs for Metastatic Malignant Melanoma
- Indication: Drugs for Hodgkin's Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing