FDA Approves Abbreviated NDA for Dasatinib Tablets in Leukemia Indications

The FDA has issued final approval for an abbreviated new drug application (ANDA) for generic dasatinib tablets at 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg across various indications, according to a press release from the developer, Alembic Pharmaceuticals.¹

Dasatinib tablets are currently indicated for the treatment of:

• Adult patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase
• Adult patients with chronic, accelerated, or myeloid or lymphoid blast phase Ph-positive CML with resistance or intolerance to prior therapy, including imatinib (Gleevec)
• Adult patients with Ph-positive acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy
• Pediatric patients 1 year of age or older with Ph-positive CML in chronic phase

The approved ANDA dasatinib tablets are therapeutically equivalent to reference dasatinib (Sprycel) tablets at 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Previously, in March 2025, the FDA approved generic dasatinib tablets at the above doses in the aforementioned indications.²

The below data are pulled from the FDA label for reference dasatinib.³

Newly Diagnosed Chronic Phase CML

The open-label, multicenter, randomized phase 3 DASISION trial (NCT00481247) randomly assigned a total of 519 patients with newly diagnosed chronic phase CML to receive either 100 mg of dasatinib once daily or 400 mg of imatinib once daily.

The confirmed complete cytogenetic response (cCR) rate was 76.8% (95% CI, 71.2%-81.8%) in the dasatinib arm compared with 66.2% (95% CI, 60.1%-71.9%) in the imatinib arm (P = .007); the median time to cCR was 3.1 months in dasatinib responders and 5.6 months in imatinib responders. The major molecular response rate was 52.1% (95% CI, 45.9%-58.3%) vs 33.8% (95% CI, 28.1%-39.9%), respectively (P <.0001); the median time to major molecular response was 6.3 months vs 9.2 months.

The median age was 46 years in the dasatinib group and 49 years in the imatinib group, with 10% and 11% of patients being 65 years or older.

The median duration of treatment was 14 months with dasatinib and 14 months with imatinib, and with a minimum of 12 months of follow-up, 85% and 81%, respectively, were still on study.

Chronic Phase CML

An open-label, randomized phase 3 trial (NCT00123474) enrolled a total of 670 patients with chronic phase CML to receive either dasatinib once daily at 100 mg or 140 mg or dasatinib twice daily at 50 mg or 70 mg.

All once-daily dasatinib treatment groups demonstrated noninferiority to the twice-daily schedule, with a difference in major cytogenetic response rate of 1.9% (95% CI, –6.8% to 10.6%).

In patients who received dasatinib once daily at 100 mg, the confirmed hematologic response rate was 92% (95% CI, 86%-95%), the major cytogenetic response rate was 63% (95% CI, 56%-71%), and the cCR rate was 50% (95% CI, 42%-58%).

In the 100 mg once daily group, the median time to major cytogenetic response was 2.9 months (95% CI, 2.8-3.0); based on Kaplan-Meier estimates, major cytogenetic responses were maintained for 18 months by 93% (95% CI, 88%-98%) of patients. The estimated rate of 2-year progression-free survival was 80% (95% CI, 73%-87%), and the estimated rate of 2-year overall survival was 91% (95% CI, 86%-96%).

Advanced Phase CML and Ph-Positive ALL

An open-label, randomized trial enrolled a total of 611 patients with advanced phase CML (lymphoid blast phase CML, myeloid blast phase CML, or accelerated phase CML) who received either dasatinib at 140 mg once daily or 70 mg twice daily.

Of those who received 140 mg once daily, patients with accelerated phase CML (n = 158) achieved a major hematologic response rate of 66% (95% CI, 59%-74%), a complete hematologic response rate of 47% (95% CI, 40%-56%), and a no evidence of leukemia rate of 19% (95% CI, 13%-26%); the major cytogenetic response rate was 39% (95% CI, 31%-47%), and the cCR rate was 32% (95% CI, 25%-40%).

In those with myeloid blast CML (n = 75), the major hematologic response rate was 28% (95% CI, 18%-40%), the complete hematologic response rate was 17% (95% CI, 10%-28%), and the no evidence of leukemia rate was 11% (95% CI, 5%-20%); the major cytogenetic response rate was 28% (95% CI, 18%-40%), and the cCR rate was 17% (95% CI, 10%-28%).

In those with lymphoid blast CML (n = 33), the major hematologic response rate was 42% (95% CI, 26%-61%), the complete hematologic response rate was 21% (95% CI, 9%-39%), and the no evidence of leukemia rate was 21% (95% CI, 9%-39%); the major cytogenetic response rate was 52% (95% CI, 34%-69%) and the cCR rate was 39% (95% CI, 23%-58%).

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. Alembic. November 7, 2025. Accessed November 7, 2025. https://tinyurl.com/3amfanm7
2. Biocon Pharma Limited secures U.S. FDA approvals for lenalidomide and dasatinib. Biocon Pharma. March 4, 2025. Accessed November 7, 2025. https://tinyurl.com/4ep82mru
3. SPRYCEL® (dasatinib) tablet for oral use. Prescribing information. FDA, 2010. Accessed November 7, 2025. https://tinyurl.com/yc7snpe5