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FDA Approval: Imatinib (Gleevec) for Leukemia
FDA approved Imatinib (Gleevec), a BCR-ABL tyrosine kinase inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Historical context: this page explains an event dated 2001. It was published as an explainer on July 12, 2026 and is not breaking news.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
In brief
FDA approved Imatinib (Gleevec) — BCR-ABL tyrosine kinase inhibitor — for certain people with leukemia. This page explains what that means in plain language and where the limits are.
Approval at a glance
| Field | Detail |
|---|---|
| Drug | Imatinib (Gleevec) |
| Regulator | FDA |
| Date | 2001 |
| Cancer type | Leukemia |
| Treatment class | BCR-ABL tyrosine kinase inhibitor |
| Eligible population | Certain people with leukemia |
| Approval type | first approval |
What was approved
Imatinib (Gleevec) (BCR-ABL tyrosine kinase inhibitor) received a first approval from the FDA for use in certain people with leukemia, reported for 2001. Eligibility is defined by the official label; whether it fits a specific person is a clinical decision.
The evidence behind it
The approval was based on the clinical evidence summarized in the FDA's announcement and the product label.
What this does and doesn't change
Approvals like this can expand options for certain people with leukemia, but they do not change care for everyone, and access, cost, and side effects still matter.
What this story cannot tell you
- An approval defines who is eligible in general terms; whether it fits a specific person is an individual clinical decision.
- Approval is not a promise of cure or of benefit for every patient — it means the evidence met the regulator's bar for this use.
- Labels and evidence can change over time as more data arrive.
Questions worth asking
- Am I in the group this treatment was approved for?
- How does it compare with my current options?
- What are the costs, logistics, and side effects?
Sources
This article was written from the sources below, which were checked on the source-check date shown above.
- FDA/AACR Approval Summary: imatinib mesylate for CML (official)
- Gleevec (imatinib) FDA approval history (secondary)
How this article was prepared
Prepared by Cancer Explained's AI-assisted editorial system and checked against the sources listed below. This article has not been reviewed by a healthcare professional unless a named reviewer is specifically shown.
Cancer Explained is published by the National Cancer Information Foundation as a nonprofit-oriented public-interest education project. It is not a diagnostic service, does not recommend treatments, and is not for emergencies.
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