Imatinib
- Generic Name
- Imatinib
- Brand Names
- Gleevec, Glivec, Imatinib Teva, Imatinib Accord
- Drug Type
- Small Molecule
- Chemical Formula
- C29H31N7O
- CAS Number
- 152459-95-5
- Unique Ingredient Identifier
- BKJ8M8G5HI
- Background
Imatinib is a small molecule kinase inhibitor that revolutionized the treatment of cancer, particularly chronic myeloid leukemia, in 2001. It was deemed a "miracle drug" due to its clinical success, as oncologist Dr. Brian noted that "complete hematologic responses were observed in 53 of 54 patients with CML treated with a daily dosage of 300 mg or more and ...
- Indication
Imatinib is indicated for the treatment of adult and pediatric chronic myeloid leukemia with Philadelphia chromosome mutation (Ph+) in blast crisis, accelerated phase, or chronic phase after IFN-alpha therapy failure.Additionally, imatinib is also indicated to treat adult and pediatric Ph+ acute lymphoblastic leukemia, adult myelodysplastic/myeloproliferativ...
- Associated Conditions
- Accelerated Phase Chronic Myelogenous Leukemia (CML), Aggressive Systemic Mastocytosis, Chordomas, Chronic Eosinophilic Leukemia, FIP1L1-PDGFRα fusion kinase status unknown Chronic eosinophilic leukemia, FIP1L1-PDGFRα fusion kinase status unknown Hypereosinophilic syndrome, Gastrointestinal Stromal Tumor (GIST), Hypereosinophilic Syndrome (HES), Metastatic Gastrointestinal Stromal Tumor (GIST), Metastatic Melanoma, Myelodysplastic Syndrome, Myeloproliferative Disorders (MPD), Refractory Acute Lymphoblastic Leukemia (ALL), Blast phase Chronic myeloid leukemia, CKit mutational status unknown Aggressive systemic mastocytosis, Metastatic Dermatofibrosarcoma protuberans, Newly diagnosed Acute Lymphoblastic Leukaemia, Newly diagnosed, chronic phase Chronic myeloid leukemia, Recurrent Dermatofibrosarcoma protuberans, Refractory, chronic phase Chronic myeloid leukemia, Unresectable Gastrointestinal stromal tumor
- Associated Therapies
- -
ASC4FIRST Trial Supports Asciminib With Secondary End Points in CML
Asciminib (Scemblix) demonstrated superior efficacy and safety compared to investigator-selected tyrosine kinase inhibitors (IS-TKIs) in chronic myeloid leukemia (CML), with a 96-week major molecular response (MMR) rate of 74.1% vs 52.0% for IS-TKIs, meeting key secondary end points of the phase 3 ASC4FIRST trial. The FDA accelerated approval of asciminib was based on 48-week MMR data showing a 68% rate with asciminib vs 49% with IS-TKIs. Asciminib's safety profile continued to outperform imatinib and second-generation TKIs, with a 54% lower risk of treatment discontinuation due to adverse effects.
Related Clinical Trials:
Scemblix May Outperform Standard Treatments for Chronic Myeloid Leukemia
Scemblix (asciminib) outperformed standard tyrosine kinase inhibitors in treating chronic myeloid leukemia, with higher response rates and fewer side effects, according to 96-week data from the phase 3 ASC4FIRST trial. The major molecular response rate was 74.1% with Scemblix versus 52% with IS-TKIs, and safety and tolerability were more favorable with Scemblix.
Asciminib Continues to Best SOC TKIs as Secondary End Points of ASC4FIRST Trial are Met
Asciminib (Scemblix) outperformed standard-of-care tyrosine kinase inhibitors in CML, achieving superior major molecular response rates at 96 weeks in the ASC4FIRST trial. The FDA accelerated approval of asciminib was based on 48-week data, and 96-week data further demonstrated its efficacy and safety profile.
Related Clinical Trials:
Olverembatinib May Be Effective in Second Line for CP-CML
Olverembatinib shows potential as a safe and effective second-line treatment for chronic-phase chronic myeloid leukemia (CP-CML) patients resistant or intolerant to first-line TKIs, particularly second-generation TKIs. In a study, 74.1% achieved complete cytogenic response (CCyR) and 40.6% major molecular response (MMR) at a median follow-up of 16 months, with no new safety concerns. The treatment, given orally every other day, improved efficacy over time and was well-tolerated.
Allosteric Inhibitor Shows “Best-in-Class” Potential in Phase I CML Study
Terns Pharmaceuticals announced positive Phase I data for its allosteric BCR-ABL inhibitor TERN-701 in relapsed/refractory CML patients, showing 50% MMR rate at three months. TERN-701, a new class of CML drugs, demonstrated safety and efficacy across dosing levels, with no dose-limiting toxicities and potential for improved efficacy and ease of use.
Dr. Brian Druker Resigns as Head of OHSU's Knight Cancer Institute
Dr. Brian Druker resigns as CEO of OHSU Knight Cancer Institute, citing internal turmoil and loss of mission focus. He plans to return to his lab and patient care, seeking new opportunities for impact.
FDA Approves New Imatinib Oral Formulation for Ten New Cancer Indications
The FDA approved Imkeldi, a new Imatinib oral formulation by Shorla Oncology, for 10 new indications in leukemias and other cancers in pediatric and adult patients. Imkeldi, a tyrosine kinase inhibitor, offers precise dosing and is a convenient alternative for patients with swallowing difficulties. Indications include Ph+ CML, Ph+ ALL, MDS/MPD, and GIST. Common adverse reactions include edema, nausea, and vomiting. Liver function and hematologic toxicity should be monitored, and grapefruit juice and breastfeeding are contraindicated.
FDA Approves Oral Liquid Solution of Imatinib for Certain Forms of Leukemia and Other Cancers
The FDA approved an oral solution of imatinib (Imkeldi; Shorla Oncology) for treating certain leukemias and cancers, marking the first oral liquid form of imatinib for cancer treatment. This flavored, stable formulation, containing 80 mg of imatinib per milliliter, aims to improve dosing accuracy and patient adherence. Imatinib, initially approved in 2001 for chronic myeloid leukemia, now has expanded indications including Ph+ CML, Ph+ ALL, myelodysplastic/myeloproliferative diseases, and others. Common adverse events include edema, nausea, and fatigue, with more severe risks like hematologic toxicities and dermatologic issues.
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FDA OKs Ninlotinib Tablets With No Mealtime Restrictions for CML
The FDA approved nilotinib (Danziten) without mealtime restrictions for adults with newly diagnosed or resistant/intolerant Philadelphia chromosome-positive chronic myeloid leukemia (CML). Danziten, a re-engineered nilotinib, offers equivalent efficacy to Tasigna but without fasting requirements, addressing Tasigna's bioavailability issues and QT interval prolongation when taken with food.
Drug Development Updates
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