GLEEVEC
LOE ApproachingNDAORALCAPSULEPriority Review
Approved
May 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
GLEEVEC by Novartis is protein-tyrosine kinase inhibitor that inhibits the bcr-abl tyrosine kinase, the constitutive abnormal tyrosine kinase created by the philadelphia chromosome abnormality in cml. First approved in 2001.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLEEVEC (imatinib) is an oral small-molecule protein-tyrosine kinase inhibitor approved in 2001 for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It works by blocking the BCR-ABL tyrosine kinase abnormality caused by the Philadelphia chromosome in CML, and also inhibits c-Kit and PDGF receptors. GLEEVEC induces apoptosis and halts proliferation of leukemic and GIST cells both in vitro and in vivo.
$0.073BPart D
LOE ApproachingAs GLEEVEC approaches loss of exclusivity, the brand team is likely consolidating and shifting focus toward lifecycle management and transition planning rather than growth expansion.
Mechanism of Action
protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML. Imatinib inhibits proliferation and induces apoptosis in BCR-ABL positive cell lines as well as fresh leukemic cells from…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
Started Oct 2010
3 enrolled
Chronic Myeloid Leukemia (CML)Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)
Started Aug 2009
38 enrolled
Leukemia
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
Started Aug 2009
34 enrolled
Non-small Cell Lung Cancer
Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
Started Jul 2009
91 enrolled
Gastrointestinal Stromal Tumor (GIST)
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Started Jun 2009
8 enrolled
Ovarian CancerPrimary Peritoneal Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.