Axatilimab

Review

Axatilimab

No authors listed

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2024 Nov 7.

PMID: 39602561
Bookshelf ID: NBK609622

Free Books & Documents

Review

Axatilimab

No authors listed.

Free Books & Documents

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2024 Nov 7.

PMID: 39602561
Bookshelf ID: NBK609622

Excerpt

Axatilimab is a humanized monoclonal antibody to the colony stimulating factor-1 receptor that is used to treat patients with chronic graft-versus-host disease who have active disease despite having received at least two previous systemic therapies. Axatilimab therapy is often accompanied by transient serum enzyme elevations, but it has not been linked to instances of clinically apparent liver injury with jaundice.

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1. Zimmerman HJ. Drugs used to treat rheumatic and musculospastic disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 517-54.(Expert review of hepatotoxicity published in 1999, before the availability of most monoclonal antibody therapies).
1. Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 569-91.(Review of hepatotoxicity of immunosuppressive agents before the availability of axatilimab).
1. Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and tolerogens. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 637-53.(Textbook of pharmacology and therapeutics).
1. Multi-Discipline Review FDA.. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761411Orig1s000T...(FDA website with product labels and initial multidiscipline clinical review of the safety and efficacy of axatilimab based on results from registration trials in support of its approval as therapy of chronic graft-vs-host disease [GvHD] mentions that in the safety cohort of 279 patients treated with axatilimab, ALT elevations arose in 12.7% of patients on 0.3 mg/kg, 21.5% on 1 mg/kg, and 40% on 3 mg/kg and values rose above 5 times ULN in 1.3%, 1.9% and 2.5%, but there were no ALT elevations with jaundice or serious hepatic adverse events).
1. Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, et al. Axatilimab for chronic graft-versus-host disease after failure of at least two prior systemic therapies: results of a phase I/II study. J Clin Oncol. 2023;41:1864-1875.(Among 40 patients 6 years of age or older with active, chronic GvHD after at least 2 systemic lines of therapy treated with varying doses of axatilimab intravenously every 4 weeks, the overall response rate was 80% and dose limiting toxicities included myopathy and pancreatitis; and while ALT, AST, Alk P, lipase, and amylase elevations were frequent they were without end-organ damage). - PMC - PubMed

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[1] Zimmerman HJ. Drugs used to treat rheumatic and musculospastic disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 517-54.(Expert review of hepatotoxicity published in 1999, before the availability of most monoclonal antibody therapies).

[2] Zimmerman HJ. Drugs used to treat rheumatic and musculospastic disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 517-54.(Expert review of hepatotoxicity published in 1999, before the availability of most monoclonal antibody therapies).

[3] Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 569-91.(Review of hepatotoxicity of immunosuppressive agents before the availability of axatilimab).

[4] Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 569-91.(Review of hepatotoxicity of immunosuppressive agents before the availability of axatilimab).

[5] Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and tolerogens. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 637-53.(Textbook of pharmacology and therapeutics).

[6] Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and tolerogens. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 637-53.(Textbook of pharmacology and therapeutics).

[7] Multi-Discipline Review FDA.. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761411Orig1s000T...(FDA website with product labels and initial multidiscipline clinical review of the safety and efficacy of axatilimab based on results from registration trials in support of its approval as therapy of chronic graft-vs-host disease [GvHD] mentions that in the safety cohort of 279 patients treated with axatilimab, ALT elevations arose in 12.7% of patients on 0.3 mg/kg, 21.5% on 1 mg/kg, and 40% on 3 mg/kg and values rose above 5 times ULN in 1.3%, 1.9% and 2.5%, but there were no ALT elevations with jaundice or serious hepatic adverse events).

[8] Multi-Discipline Review FDA.. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761411Orig1s000T...(FDA website with product labels and initial multidiscipline clinical review of the safety and efficacy of axatilimab based on results from registration trials in support of its approval as therapy of chronic graft-vs-host disease [GvHD] mentions that in the safety cohort of 279 patients treated with axatilimab, ALT elevations arose in 12.7% of patients on 0.3 mg/kg, 21.5% on 1 mg/kg, and 40% on 3 mg/kg and values rose above 5 times ULN in 1.3%, 1.9% and 2.5%, but there were no ALT elevations with jaundice or serious hepatic adverse events).

[9] Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, et al. Axatilimab for chronic graft-versus-host disease after failure of at least two prior systemic therapies: results of a phase I/II study. J Clin Oncol. 2023;41:1864-1875.(Among 40 patients 6 years of age or older with active, chronic GvHD after at least 2 systemic lines of therapy treated with varying doses of axatilimab intravenously every 4 weeks, the overall response rate was 80% and dose limiting toxicities included myopathy and pancreatitis; and while ALT, AST, Alk P, lipase, and amylase elevations were frequent they were without end-organ damage). - PMC - PubMed

[10] Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, et al. Axatilimab for chronic graft-versus-host disease after failure of at least two prior systemic therapies: results of a phase I/II study. J Clin Oncol. 2023;41:1864-1875.(Among 40 patients 6 years of age or older with active, chronic GvHD after at least 2 systemic lines of therapy treated with varying doses of axatilimab intravenously every 4 weeks, the overall response rate was 80% and dose limiting toxicities included myopathy and pancreatitis; and while ALT, AST, Alk P, lipase, and amylase elevations were frequent they were without end-organ damage). - PMC - PubMed

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Axatilimab

Axatilimab

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