FDA Approves Generic Dasatinib, Expanding Access to Key TKI

The US FDA has granted final approval for an abbreviated new drug application (ANDA) for generic dasatinib (Sprycel) tablets in multiple dosage strengths, a regulatory milestone set to improve market access and cost efficiency for a critical therapeutic agent in the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).¹

This approval covers 20-mg, 50-mg, 70-mg, 80-mg, 100-mg, and 140-mg tablets, which have been designated as therapeutically equivalent to the reference listed drug.

Efficacy in Frontline Chronic Myeloid Leukemia

Dasatinib, a potent, oral, multitargeted tyrosine kinase inhibitor (TKI), demonstrated superior efficacy as a first-line treatment for adult patients with newly diagnosed Ph+ CML in chronic phase (CML-CP) compared with imatinib (Gleevec), the original first-generation TKI. The foundational evidence supporting this indication was derived from the phase 3, open-label, randomized DASISION trial (NCT00481247). In this study, 519 patients were randomized to receive either dasatinib (100 mg once daily) or imatinib (400 mg once daily).²

Key end points favored the dasatinib arm, with patients achieving faster and deeper responses. The confirmed complete cytogenetic response (cCCyR) rate was 76.8% in the dasatinib cohort, significantly higher than the 66.2% reported in the imatinib arm (P = .007). Moreover, the major molecular response (MMR) rate was 52.1% for dasatinib vs 33.8% for imatinib (P < .0001). The median time to cCCyR was 3.1 months for dasatinib responders compared with 5.6 months for imatinib responders, highlighting the agent’s rapid therapeutic effect. These data established dasatinib as a standard frontline option due to its ability to induce early and robust molecular responses, which are correlated with improved long-term outcomes in CML-CP.

Role in Advanced and Refractory Disease

Beyond the frontline setting, dasatinib is indicated for adult patients with chronic, accelerated, or myeloid or lymphoid blast phase CML, as well as Ph+ ALL who exhibit resistance or intolerance to prior TKI therapy, including imatinib. The agent's mechanism, which involves inhibition of BCR-ABLand other relevant kinases, provides activity against a spectrum of imatinib-resistant BCR-ABL point mutations (excluding T315I).³

In a randomized phase 3 trial (NCT00123474) evaluating dosing schedules in CML-CP patients with imatinib resistance or intolerance, the 100 mg once-daily dose established a major cytogenetic response rate of 63% (95% CI, 56%-71%). In advanced disease, trials demonstrated clinical benefit across phases. For adult patients with accelerated phase CML, dasatinib (140 mg once daily) achieved a major hematologic response rate of 66%. In lymphoid blast CML, a major cytogenetic response rate of 52% and a complete cytogenetic response rate of 39% were reported in the same cohort, demonstrating potent activity in highly aggressive disease states.

Pediatric Indications and Safety Profile

Dasatinib is also approved for the treatment of pediatric patients aged 1 year and older with Ph+ CML in chronic phase and for Ph+ ALL in combination with chemotherapy. The expanded indication for pediatric Ph+ ALL in combination with chemotherapy was supported by the phase 2 CA180-372 trial (NCT01460160). In this study of newly diagnosed patients with B-cell precursor Ph+ patients, the combination therapy regimen resulted in a 3-year event-free survival (EFS) binary rate of 64.1% (95% CI, 52.4%-74.7%). An impressive 96% of patients achieved a bone marrow blast percentage of less than 5% at the end of induction therapy.⁴

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. Alembic Pharmaceuticals Limited. News release. November 7, 2025. Accessed November 11, 2025. https://tinyurl.com/yfp28wdy

2. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-2270. doi:10.1056/NEJMoa1002315.

3. Shah NP, Guilhot F, Cortes JE, et al. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014;123(15):2317-2324. doi:10.1182/blood-2013-10-532341.

4. SPRYCEL® (dasatinib) pediatric efficacy. Sprycel HCP. Accessed November 11, 2025. https://www.sprycel-hcp.com/efficacy-pediatric-patients