Two medicines, side by side
Bosutinib vs dasatinib
Bosutinib and dasatinib are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of bosutinib since 2012 and of dasatinib since 2006. How each works, in its label's words: Bosutinib, “Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck.”; Dasatinib, “Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ.”
Check it at the source: the bosutinib FDA label on DailyMed (effective March 10, 2026); the dasatinib FDA label on DailyMed (effective November 12, 2025).
Highlights of the bosutinib record
Bosutinib (Bosulif) · label of March 10, 2026
Used for
From the label: indicationsBOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. […]
On the market
- Earliest approval on file
- September 4, 2012
- Generic labelers
- 3 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the dasatinib record
Dasatinib (Sprycel) · label of November 12, 2025
Used for
From the label: indicationsDasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. […]
On the market
- Earliest approval on file
- June 28, 2006
- Generic labelers
- 14 labelers
- Pharmacy cost
- $26.46 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Bosutinib label of March 10, 2026, Dasatinib label of November 12, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do bosutinib and dasatinib differ on the record?
How each works, in its label's words: Bosutinib, “Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck.”; Dasatinib, “Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ.”
Both are in FDA's class kinase inhibitors.
Generics: bosutinib since 2025; dasatinib since 2016 (Drugs@FDA).
| Bosutinib | Dasatinib | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma | Leukemia, lymphoma and myeloma |
| Pharmacologic class | Kinase Inhibitor | Kinase Inhibitor |
| How it works (label) | Bosutinib is a TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. | Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. |
| Half-life (label) | n/a | Elimination The mean terminal half-life of dasatinib is 3 hours to 5 hours. |
| Earliest approval on file (Drugs@FDA) | September 4, 2012 | June 28, 2006 |
| First generic approved | May 23, 2025 | June 10, 2016 |
| Generic labelers (NDC) | 3 labelers | 14 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | $26.46 per tablet (Dasatinib 100 mg tablet) |
| 12-month price change | n/a | -86% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,931 | 9,103 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to bosutinib
- every medicine labeled for the same conditions