Axatilimab

Overview

Axatilimab is under investigation in clinical trial NCT04301778 (Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-embolization for Patients With Intrahepatic Cholangiocarcinoma).

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation	2025/06/11	NCT07015853	Phase 2	Not yet recruiting	Stephen Shiao
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease	2025/06/10	NCT07011810	Phase 2	Not yet recruiting	Fred Hutchinson Cancer Center
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD	2025/02/25	NCT06843408	Phase 1	Recruiting	Incyte Corporation
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy	2025/02/12	NCT06821542	Phase 3	Recruiting	Incyte Corporation
A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants	2024/12/03	NCT06713590	Phase 1	Completed	Incyte Corporation
Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease	2024/10/29	NCT06663722	Phase 2	Recruiting	University of Miami
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease	2024/09/19	NCT06585774	Phase 3	Recruiting	Incyte Corporation
Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia	2024/07/26	NCT06523556	Phase 1	Recruiting	Uma Borate
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease	2024/04/29	NCT06388564	Phase 2	Recruiting	Incyte Corporation
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors	2024/03/20	NCT06320405	Phase 1	Recruiting	OHSU Knight Cancer Institute

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Specialised Therapeutics Expands Incyte Partnership to Bring Two Novel Cancer Therapies to Asia-Pacific

25 days ago

Specialised Therapeutics has expanded its partnership with Incyte to include axatilimab and retifanlimab for distribution in Australia, New Zealand, and Singapore, with potential expansion to other Asia-Pacific countries.

Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

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Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.

FDA Approval of Axatilimab Marks New Era in Chronic GVHD Treatment

4 months ago

Axatilimab, a CSF1R-blocking antibody, received FDA approval in August 2024 for chronic graft-versus-host disease treatment, demonstrating a 74% overall response rate in clinical trials.

Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones

5 months ago

Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M).

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6 months ago

The FDA has approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes for chronic graft-versus-host disease (GVHD) after two prior systemic therapies.

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