An experimental treatment has kept one patient with heavily pretreated hairy cell leukemia free of detectable disease for more than two years, raising questions about whether CAR T-cell therapy could offer a path toward a cure.
News|Articles|September 18, 2026
5 Years of Leukemia Advances: A Timeline of FDA Approvals and What They Mean for Patients
Author(s)Quincy Attobrah
Fact checked by: CURE staff
See 5 years of FDA leukemia approvals for CLL, AML and CML — new drugs, new drug classes, and how many patients they've actually helped.
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If you or someone you love has leukemia, it helps to understand something up front: "leukemia" isn't one disease. Chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML) are genetically and clinically very different cancers that happen to share a name. But looking at what the FDA has actually approved over the last five years shows the same underlying story playing out in all three — a drug proves itself in the hardest cases and earns approval there first, then either gets approved for earlier use or a completely new kind of drug is approved where nothing worked before. Every treatment below reached patients because it cleared that FDA approval bar, based on real trial data reviewed by the agency — not early promise or a company's own claims.
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