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Sprycel (dasatinib)
Sprycel works by blocking the activity of a specific protein called Ephrin type-B receptor 6, which is involved in the growth and survival of cancer cells.
At a glance
| Generic name | dasatinib |
|---|---|
| Sponsor | Handa Therap |
| Drug class | dasatinib |
| Target | Ephrin type-B receptor 6 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2006 |
| Annual revenue | 493 |
Mechanism of action
Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFR. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib could overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.
Approved indications
- Blastic phase chronic myeloid leukemia
- Chronic Myelocytic Leukemia Accelerated Phase
- Chronic phase chronic myeloid leukemia
- Philadelphia Chromosome Positive Chronic Myelocytic Leukemia
- Philadelphia chromosome-positive acute lymphoblastic leukemia
Common side effects
- Myelosuppression
- Fluid retention events
- Diarrhea
- Headache
- Skin rash
- Hemorrhage
- Dyspnea
- Fatigue
- Nausea
- Musculoskeletal pain
- Mucositis
- Febrile neutropenia
Drug interactions
- boceprevir
- carbamazepine
- conivaptan
- dexamethasone
- fosphenytoin
- indinavir
- itraconazole
- ketoconazole
- lansoprazole
- mibefradil
- nefazodone
- nelfinavir
Key clinical trials
- Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia (PHASE1)
- Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia (PHASE2)
- Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML (PHASE3)
- A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia (PHASE3)
- Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML (PHASE3)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7491725 | 2026-03-28 | Compound |
| 7491725*PED | 2026-09-28 | Compound |
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 |
| SEC EDGAR | Revenue + earnings |