Retifanlimab

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Retifanlimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetProgrammed cell death protein 1 (PD-1)
Names
Trade namesZynyz
Other namesRetifanlimab-dlwr
Clinical data
Main usesMerkel cell carcinoma[1]
Side effectsTiredness, muscle pain, itchiness, diarrhea, fever, nausea, immune disorders[1]
Routes of
use		Intravenous
Typical dose500 mg q 4 weeks[1]
Legal
License data
Legal status
Chemical and physical data
FormulaC6456H9934N1702O2032S46
Molar mass145381.13 g·mol−1

Retifanlimab, sold under the brand name Zynyz, is a medication used to treat Merkel cell carcinoma.[1] Specifically it is used for advanced disease.[1] It is given by injection into a vein.[1]

Common side effects include tiredness, muscle pain, itchiness, diarrhea, fever, and nausea.[1] Other side effects may include immune mediated disorders including hepatitis, colitis, and pneumonitis and infusion reactions.[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody which blocks programmed death receptor-1 (PD-1).[1]

Retifanlimab was approved for medical use in the United States in 2023.[1] As of 2023 in the United States it costs about 15,000 USD per dose.[3]

Medical uses

Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[2][4]

Dosage

It is given as a dose of 500 mg every 4 weeks.[1]

History

The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, single-arm study of 65 people with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.[4]

The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.[4]

Society and culture

Names

Retifanlimab is the international nonproprietary name.[5]

References

  1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 "DailyMed - ZYNYZ- retifanlimab-dlwr injection". dailymed.nlm.nih.gov. Archived from the original on 1 July 2023. Retrieved 12 June 2023.
  2. ↑ 2.0 2.1 "Archived copy" (PDF). Archived (PDF) from the original on 23 March 2023. Retrieved 23 March 2023.{{cite web}}: CS1 maint: archived copy as title (link)
  3. ↑ "Zynyz Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 1 July 2023. Retrieved 12 June 2023.
  4. ↑ 4.0 4.1 4.2 "FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma". U.S. Food and Drug Administration (FDA). 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

External links

Identifiers:
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