FLT3 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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The receptor tyrosine kinase FMs-like tyrosine kinase 3 (FLT3) is involved in regulating the survival, proliferation, and differentiation of hematopoietic stem/progenitor cells and is expressed in cancer cells. FL-T3 mutations cause ligand-independent cell survival, proliferation, and resistance to apoptosis. FLT3 inhibitors interact with the ATP- binding site of the intracellular tyrosine kinase domain and competitively inhibit ATP binding, thereby preventing autophosphorylation and activation of downstream signaling. FLT3 inhibitors are used in the treatment of chronic myeloid leukemia, precursor cell lymphoblastic leukemia-lymphoma, liver cancer, renal cell carcinoma, thyroid cancer, and others. Sanofi, Bayer, Novartis, Bristol-Myers Squibb, Takeda Oncology, and Exelixis are some of the major players in the market for FLT3 inhibitors. Additionally, there are several drug molecules in the clinical trial phases of pharmaceutical companies for other indications.

Key Market Developments:

  • In Feb 2023, FDA granted seven years of orphan drug exclusive approval for Pacritinib for the treatment of myelofibrosis in the USA to CTI BioPharma.
  • In Apr 2023, PDUFA action date was extended to 24/07/2023 for NDA for FLT3-ITD positive acute myeloid leukemia by US FDA for Daiichi Sankyo Company’s Quizartinib.

Approved Drug Molecules and Brand Names for FLT3 Inhibitors:

  • Sorafenib (Nexavar)
  • Sutent (Sunitinib)
  • Cabometyx (Cabozantinib tablet)
  • Nintedanib
  • Iclusig (Ponatinib)
  • Cometriq (Cabozantinib capsule)
  • Xospata (Gilteritinib)
  • Vonjo (Pacritinib)
  • Vanflyta (Quizartinib)

Drugs under the Pipeline for FLT3 Inhibitors:

  • Dovitinib (TKI258)
  • Rydapt (Midostaurin)
  • Famitinib (SHR 1020)
  • Alunbrig (Brigatinib)
  • Inrebic (Fedratinib)
  • Turalio (Pexidartinib)
  • Crenolanib (ARO-002)
  • Linifanib (ABT-869)
  • Lestaurtinib (CEP-701)
  • Mivavotinib (CB-659)
  • Gavreto (Pralsetinib)
  • Qinlock (Ripretinib)
  • Ruserontinib (SKLB-1028)
  • ENMD-2076
  • Max-40279
  • Tandutinib (MLN518)
  • Zotiraciclib (TG02)
  • Ningetinib (CT053PTSA)
  • Emavusertib (CA-4948)
  • KC1036
  • MRX2843
  • Amuvatinib (MP470)
  • Clifutinib (HEC73543)
  • Rebastinib (DCC-2036)
  • XY0206
  • Flonoltinib

Clinical Activity and Developments of FLT3 Inhibitors:

There are more than 60 products, including about 10 approved drug products and other drugs in the clinical trial phases.

  • In Feb 2023, Bristol-Myers Squibb, in collaboration with Exelixis, initiated a phase-II CANOPY trial for prostate cancer in the USA for Cabozantinib (Cometriq).
  • In March 2023, Incyte Biosciences International and University Hospital Frankfurt completed a phase-II trial in precursor cell lymphoblastic leukemia-lymphoma in Germany for Ponatinib.

Molecule Name

Number of Studies

Dovitinib (TKI258)


Rydapt (Midostaurin)


famitinib (SHR 1020)


Alunbrig (Brigatinib)


Inrebic (Fedratinib)


Turalio (Pexidartinib)


Crenolanib (ARO-002)


Linifanib (ABT-869)


Lestaurtinib (CEP-701)


Mivavotinib (CB-659)


Gavreto (Pralsetinib)


Qinlock (Ripretinib)


Ruserontinib (SKLB-1028)






Tandutinib (MLN518)


Zotiraciclib (TG02)


Ningetinib (CT053PTSA)


Emavusertib (CA-4948)






Amuvatinib (MP470)


Clifutinib (HEC73543)


Rebastinib (DCC-2036)






Target Indication Analysis of FLT3 Inhibitors

Ponatinib is indicated for chronic myeloid leukemia and precursor cell lymphoblastic leukemia-lymphoma and it is in phase-II for acute myeloid leukemia, biliary cancer, gastrointestinal stromal tumors, lung cancer, squamous cell cancer, and thyroid cancer. Cabozantinib and Sorafenib are marketed for liver cancer, renal cell carcinoma, and thyroid cancer.  Cabozantinib is also in phase-III for non-small cell lung cancer and prostate cancer. Sunitinib is used in the treatment of gastrointestinal stromal tumors, pancreatic cancer, and renal cell carcinoma and is in phase-II for alveolar soft part carcinoma, bladder cancer, neuroendocrine tumors, oesophageal cancer, phaeochromocytoma, prostate cancer, and uveal melanoma.

Frequently Asked Questions

Sorafenib (Nexavar), Sutent (Sunitinib), Cabometyx (Cabozantinib tablet), Nintedanib, and Iclusig (Ponatinib) are some of the approved FLT3 inhibitors in the market.

Sanofi, Bayer, Novartis, Bristol-Myers Squibb, Takeda Oncology, and Exelixis are some of the major players in the market for FLT3 inhibitors.

Major indications for FLT3 inhibitors are chronic myeloid leukemia, metastatic malignant gastrointestinal stromal tumor, precursor cell lymphoblastic leukemia-lymphoma, liver cancer, renal cell carcinoma, and thyroid cancer.

There are more than 30 drug molecules in clinical development for FLT3 inhibitors.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Novartis
  • Exelixis
  • Bayer
  • Jiangsu Hengrui Pharma
  • Astellas Pharma
  • Takeda Pharmaceuticals
  • BMS
  • AbbVie
  • Blueprint Medicines
  • Reddy's Laboratories
  • Otsuka Pharmaceutical
  • Roche
  • Amgen

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