Two medicines, side by side
Bosutinib vs imatinib
Bosutinib and imatinib are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of bosutinib since 2012 and of imatinib since 2001. 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.”; Imatinib, “Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML.”
Check it at the source: the bosutinib FDA label on DailyMed (effective March 10, 2026); the imatinib FDA label on DailyMed (effective September 8, 2026).
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 imatinib record
Imatinib (Gleevec) · label of September 8, 2026
Used for
From the label: indicationsImatinib mesylate is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 ) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2 […]
On the market
- Earliest approval on file
- May 10, 2001
- Generic labelers
- 20 labelers
- Pharmacy cost
- $0.624 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Source: FDA drug labels via openFDA (Bosutinib label of March 10, 2026, Imatinib label of September 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do bosutinib and imatinib 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.”; Imatinib, “Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML.”
Both are in FDA's class kinase inhibitors.
Generics: bosutinib since 2025; imatinib since 2015 (Drugs@FDA).
| Bosutinib | Imatinib | |
|---|---|---|
| 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. | Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML. |
| Half-life (label) | n/a | Apparent oral clearance was similar to adult values (11.0 L/hr/m 2 in children vs 10.0 L/hr/m 2 in adults), as was the half-life (14.8 hours in children vs 17.1 hours in adults). |
| Earliest approval on file (Drugs@FDA) | September 4, 2012 | May 10, 2001 |
| First generic approved | May 23, 2025 | December 3, 2015 |
| Generic labelers (NDC) | 3 labelers | 20 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | $0.624 per tablet (Imatinib mesylate 100 mg tablet) |
| 12-month price change | n/a | -32% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,931 | 41,417 |
| 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)
Do their labels mention each other?
Bosutinib label, warnings and precautionsIn a randomized study of adult patients with newly diagnosed CML, cardiac failure occurred in 1.9% of patients treated with BOSULIF compared to 0.8% of patients treated with imatinib.
Source: FDA drug labels via openFDA
What next?
- Alternatives to bosutinib
- every medicine labeled for the same conditions