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  • Anti-PD-1 immunotherapy 'Zynyz' gets ODD in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Jun 16, 2025 06:02am
Secured indication to treat Merkel cell carcinoma (MCC) with limited treatment options
Recently won approval in the U.S. for expanded indication to treat anal squamous cell carcinoma
 ¡ã Product photo of Zynyz (retifanlimab)
The checkpoint inhibitor immunotherapy 'Zynyz' has been designated as an orphan drug in South Korea.

The Ministry of Food and Drug Safety (MFDS) has recently announced this through its notification board.

It is indicated to treat relapsed or metastatic locally advanced Merkel cell carcinoma (MCC).

Zynyz (retifanlimab) obtained U.S. approval in 2023 through the FDA's expedited approval program.

MCC is associated with fast cancer cell growth and high metastatic rate, thus known for poor prognosis. Therefore, a first-line treatment option that can bring about a continuous response in metastatic MCC patients is necessary.

The basis of accelerated approval of Zynyz is the Phase 2 PODIUM-201 study involving
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