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Dtic-Dome (dacarbazine)
Dtic-Dome (dacarbazine) is a small molecule alkylating drug developed by Bayer Healthcare, targeting matrix metalloproteinase-9. It was FDA-approved in 1975 for the treatment of Hodgkin's disease and metastatic malignant melanoma. As an off-patent medication, Dtic-Dome is available from multiple generic manufacturers. Key safety considerations include its potential for severe myelosuppression and gastrointestinal toxicity. The commercial status of Dtic-Dome is off-patent, with no active Orange Book patents.
At a glance
| Generic name | dacarbazine |
|---|---|
| Sponsor | Bayer |
| Drug class | Alkylating Drug [EPC] |
| Target | Matrix metalloproteinase-9 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1975 |
Approved indications
- Hodgkin's disease
- Metastatic malignant melanoma
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
- Nausea
- Vomiting
- Diarrhea
- Influenza-like syndrome
- Fever
- Myalgias
- Malaise
- Alopecia
- Facial flushing
- Facial paresthesia
- Erythematous rash
- Urticarial rash
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 |