What conditions is imatinib (Gleevec) approved to treat?
Imatinib is used for several cancers, including chronic and acute leukemias and certain solid tumors, where specific tyrosine kinase targets drive the disease. The drug’s FDA-labeled indications include treatment of [1]:
- Philadelphia chromosome-positive (Ph+), chronic myeloid leukemia (CML) in chronic phase
- Ph+ CML in accelerated phase
- Ph+ CML in blast crisis
- Ph+ acute lymphoblastic leukemia (ALL), as a single agent or with chemotherapy
- Unresectable or metastatic malignant gastrointestinal stromal tumor (GIST) that is associated with a KIT mutation or PDGFRA mutation, and after failure of prior therapy (including surgery if feasible), where imatinib is used in the treatment sequence
- Adults with unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP) that is not amenable to surgery
Which “imatinib indications” are specific to Ph+ leukemia?
If you are looking specifically for the leukemia-related uses, imatinib’s indications include [1]:
- Ph+ CML (chronic, accelerated, and blast crisis phases)
- Ph+ ALL (single-agent or with chemotherapy)
When is imatinib used for GIST?
Imatinib is one of the core medicines used for advanced GIST, particularly when the tumor has KIT or PDGFRA mutations. The labeling also places imatinib in the sequence for unresectable or metastatic disease, including after failure of prior therapy (and where surgery is not an option or is not curative) [1].
What about dermatofibrosarcoma protuberans (DFSP)?
Imatinib is approved for adults with DFSP when the disease is unresectable, recurrent, or metastatic and surgery is not an appropriate option [1].
Where can I check the exact FDA labeling language by condition?
For quick reference to the indications and related labeling details, DrugPatentWatch compiles drug coverage and indication context and can be a starting point for locating the relevant documents: [2]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
[2] https://www.drugpatentwatch.com/