Why FDA Said No to a Melanoma Drug - Takeaways - MDSpire
FDA & Government News

Why FDA Said No to a Melanoma Drug

Questions over trial design and political pressure shadowed the rejection of Replimune’s RP1 treatment.

  • By

  • Arthur Allen

  • May 15, 2026

  • 9 min

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  • 1

    FDA rejected RP1 for melanoma treatment despite trial success.

  • 2

    112,000 new cases of melanoma diagnosed annually in the US.

  • 3

    33% of trial patients showed tumor response.

  • 4

    Control arm absence raised FDA concerns.

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    Regulatory trust issues highlighted due to recent FDA leadership changes.

Original Source(s)

Why FDA Said No to a Melanoma Drug

  • by Arthur Allen

  • May 15, 2026

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