Retifanlimab Explained
| Type: | mab |
| Mab Type: | mab |
| Source: | zu |
| Target: | Programmed cell death protein 1 (PD-1) |
| Tradename: | Zynyz |
| Dailymedid: | Retifanlimab |
| Routes Of Administration: | Intravenous |
| Atc Prefix: | L01 |
| Atc Suffix: | FF10 |
| Legal Us: | Rx-only |
| Legal Us Comment: | [1] |
| Cas Number: | 2079108-44-2 |
| Drugbank: | DB15766 |
| Unii: | 2Y3T5IF01Z |
| Kegg: | D11827 |
| Synonyms: | AEX-1188, INCMGA-00012, MGA-012, retifanlimab-dlwr |
| C: | 6456 |
| H: | 9934 |
| N: | 1702 |
| O: | 2032 |
| S: | 46 |
Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma. Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
It was approved for medical use in the United States in March 2023.[2] [3] [4] [5]
Medical uses
Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[6]
History
The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.
The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.
Society and culture
Legal status
In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma. The applicant for this medicinal product is Incyte Biosciences Distribution B.V.[7]
Names
Retifanlimab is the international nonproprietary name.[8]
Notes and References
- Web site: Zynyz- retifanlimab-dlwr injection . DailyMed . 22 March 2023 . 20 November 2023 . 1 July 2023 . https://web.archive.org/web/20230701233133/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=109648d0-d30a-42fc-8273-39cb1540a751 . live .
- Web site: 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 . 22 March 2023 . 23 March 2023 . https://web.archive.org/web/20230323054927/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel . live .
- Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC) . Incyte . Business Wire . 22 March 2023 . 22 March 2023 . 23 March 2023 . https://web.archive.org/web/20230323052717/https://www.businesswire.com/news/home/20230322005618/en/Incyte-Announces-FDA-Approval-of-Zynyz%E2%84%A2-retifanlimab-dlwr-for-the-Treatment-of-Metastatic-or-Recurrent-Locally-Advanced-Merkel-Cell-Carcinoma-MCC . live .
- MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of Zynyz (retifanlimab-dlwr) . MacroGenics . GlobeNewswire . 22 March 2023 . 22 March 2023 . 23 March 2023 . https://web.archive.org/web/20230323054850/https://www.globenewswire.com/news-release/2023/03/22/2632605/0/en/MacroGenics-Earns-15-Million-Milestone-Following-U-S-FDA-Approval-of-ZYNYZ-retifanlimab-dlwr.html . live .
- Kang C . Retifanlimab: First Approval . Drugs . 83 . 8 . 731–737 . June 2023 . 37184754 . 10.1007/s40265-023-01884-7 . 258687035 .
- Web site: Drug Approval Package: Zynyz . U.S. Food and Drug Administration (FDA) . 19 April 2023 . 20 November 2023 . 20 November 2023 . https://web.archive.org/web/20231120062447/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761334Orig1s000TOC.cfm . live .
- Web site: Zynyz EPAR . European Medicines Agency (EMA) . 22 February 2024 . 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 . WHO Drug Information . 34 . 1 . 2020 . 10665/339768 . free . World Health Organization .
