Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deferasirox DFX, DT · 1 trial · 1 indication
Difference in percentage of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria increase in hemoglobin (Hb) ≥ 1.5 g/dL. Erythroid response is defined as the increase in Hb from baseline ≥ 1.5 g/dL. Patients achieving erythroid response at least once within 12 weeks were considered responders
| Arm | Type | Description |
|---|---|---|
| Erythropoietin alpha | EXPERIMENTAL | Patients will receive erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement is inadequate, dose will be escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement in inadequate, patients will be switched to the combination arm. At any time when erythroid response is achieved, erythropoietin treatment will be stopped until end of study. |
| Deferasirox + Erythropoietin alpha | EXPERIMENTAL | Patients will receive deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet (FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement is inadequate, erythropoietin dose will be escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement in inadequate, patients will be discontinued from the study. At any time when erythroid response is achieved, erythropoietin treatment will be stopped until end of study. Patients will continue deferasirox treatment. |
| Name | Type | Description |
|---|---|---|
| Deferasirox DFX, DT | DRUG | provided as dispersible tablets for oral use in 125 and 250, 500 mg |
| Erythropoietin alpha | DRUG | - |
| Deferasirox DFX, FCT | DRUG | provided as film-coated tablet for oral use in 90, 180, 360 mg strengths |
Key Inclusion Criteria: * Patients who had low- and Int-1-risk myelodysplastic syndrome * Documented diagnosis of the following: Myelodysplastic syndrome that lasted ≥ 3 months and \< 3 years Disease must not have been secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy fo...
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Deferasirox DFX, DT is an investigational small molecule being studied for the treatment of Low and Int 1-risk Myelodysplastic Syndrome, a group of blood cancers. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Deferasirox DFX, DT is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Low and Int 1-risk Myelodysplastic Syndrome.
Deferasirox DFX, DT is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The drug is being studied for the treatment of Low and Int 1-risk Myelodysplastic Syndrome, and its safety and efficacy are still being evaluated in clinical trials.
Deferasirox DFX, DT has been studied in one completed clinical trial, identified as NCT01868477. This Phase 2 trial, titled "Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome," enrolled 28 participants across multiple countries including Algeria, Argentina, Canada, China, Germany, Italy, South Korea, Spain, Sweden, and the United Kingdom.
Deferasirox DFX, DT is a formulation of deferasirox, an iron chelator. The DFX, DT designation indicates a specific formulation or delivery technology. In the context of the clinical trial NCT01868477, it is being studied in combination with erythropoietin for patients with Low and Int 1-risk Myelodysplastic Syndrome.