FDA Approves Generic Dasatinib Tablets for CML, ALL

The FDA has granted final approval to an abbreviated new drug application (ANDA) for 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg tablets of dasatinib, which are therapeutically equivalent to the reference drug dasatinib (Sprycel).1

Dasatinib is approved in the following indications:2

• for the treatment of adult patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase.
• for the treatment of adult patients with chronic, accelerated, or myeloid or lymphoid blast phase, Ph-positive CML with resistance or intolerance to prior therapy, including imatinib (Gleevec).
• for the treatment of adult patients with Ph-positive acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.
• for the treatment of pediatric patients 1 year of age and older with Ph-positive CML in chronic phase.
• in combination with chemotherapy for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph-positive ALL.

The FDA previously granted tentative approval of the ANDA for generic dasatinib in June 2022.3

What is the approval history for dasatinib?

Dasatinib was initially approved by the FDA in 2006.2 Its most recent approval came in January 2019, when the regulatory agency expanded the agent's original indication to include dasatinib plus chemotherapy for pediatric patients at least 1 year of age with Ph-positive ALL.4

This approval was supported by data from the phase 2 CA180-372 trial (NCT01460160), which demonstrated that pediatric patients with newly diagnosed, B-cell precursor Ph-positive ALL (n = 78) experienced a 3-year event-free survival (EFS) binary rate of 64.1% (95% CI, 52.4%-74.7%).

Additionally, at the end of induction therapy, 96% of patients achieved a bone marrow blast percentage of less than 5%; this rate improved to 97% at the end of consolidation.2

In the safety-evaluable population (n = 81), fatal adverse effects (AEs) were reported in 4% of patients.4 AEs led to treatment discontinuation in 10% of patients; these AEs included fungal sepsis, hepatotoxicity of graft vs host disease, thrombocytopenia, CMV infection, pneumonia, nausea, enteritis, and drug hypersensitivity.

The most common serious AEs that occurred in at least 10% of patients comprised pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections (bacterial, viral, and fungal), hypersensitivity, vomiting, renal insufficiency, abdominal pain, and musculoskeletal pain.

What is the overall safety profile of dasatinib?

Per the prescribing information for dasatinib, the most common AEs reported in at least 15% of patients treated with the agent as monotherapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.2

Among pediatric patients treated with dasatinib plus chemotherapy, the most common AEs that occurred in at least 30% of patients comprised mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral, and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

The prescribing information also included warnings and precautions for myelosuppression and bleeding effects; fluid retention; cardiovascular toxicity; pulmonary arterial hypertension; QT prolongation; severe dermatologic reactions; tumor lysis syndrome; embryo-fetal toxicity; effects on growth and development in pediatric patients; and hepatotoxicity.

For adult patients with chronic phase CML, dasatinib is recommended at a dose of 100 mg once per day. For adult patients with accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph-positive ALL, the agent is recommended at 140 mg once per day.

In pediatric patients with chronic phase CML and ALL, the starting dose of dasatinib is based on body weight.

References

1. Alembic Pharmaceuticals Limited announces USFDA Final Approval for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. News release. Alembig Pharmaceuticals. November 7, 2025. Accessed November 7, 2025. https://alembicpharmaceuticals.com/webfiles/media/2025-2026/Press-Release-Dasatinib-Tablets.pdf
2. Sprycel. Prescribing information. Bristol Myers Squibb. Updated July 2024. Accessed November 7, 2025. https://packageinserts.bms.com/pi/pi_sprycel.pdf
3. Alembic Pharmaceuticals receives USFDA tentative approval for dasatinib tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. News release. Alembig Pharmaceuticals. June 10, 2022. Accessed November 7, 2025. https://alembicpharmaceuticals.com/webfiles/media/2022-2023/Press-Release-USFDA-Tentative-Approval-Dasatinib-Tablets-20-Mg-50-Mg-70-Mg-80-Mg-100-Mg-140-Mg.-June-2022.pdf
4. Bristol-Myers Squibb’s Sprycel (dasatinib) tablets now approved in combination with chemotherapy in certain pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. News release. Bristol Myers Squibb. January 2, 2019. Accessed November 7, 2025. https://news.bms.com/news/corporate-financial/2019/Bristol-Myers-Squibbs-Sprycel-dasatinib-Tablets-Now-Approved-in-Combination-with-Chemotherapy-in-Certain-Pediatric-Patients-with-Philadelphia-Chromosome-Positive-Acute-Lymphoblastic-Leukemia/default.aspx