Uveal Melanoma

• EMA approval · 2025-12-09
  EMA Authorised: Kimmtrak (tebentafusp) — Immunocore Ireland Limited

  EMA authorised Kimmtrak (tebentafusp) from Immunocore Ireland Limited for uveal melanoma, signaling EU approval of this first-in-class thera…

• FDA approval · 2025-09-04
  FDA Approved: HEPZATO KIT — Supplemental Application (Delcath Systems, Inc.)

  FDA approved a supplemental application for Hepzato Kit (melphalan hydrochloride injection, lyophilized powder, for solution) from Delcath S…

• FDA approval · 2024-06-27
  FDA Approved: KIMMTRAK — Supplemental Application (Immunocore Commercial LLC)

  FDA approved a supplemental Biologics License Application for KIMMTRAK (tebentafusp) from Immunocore Commercial LLC.

• FDA approval · 2023-08-14
  FDA Approved: HEPZATO KIT — Original Application (Delcath Systems, Inc.)

  The FDA approved HEPZATO KIT, a lyophilized melphalan hydrochloride injection, for isolated hepatic perfusion in adults with unresectable li…

• FDA approval · 2022-11-29
  FDA Approved: KIMMTRAK — Supplemental Application (Immunocore Commercial LLC)

  FDA approved a supplemental application for KIMMTRAK (tebentafusp) filed by Immunocore Commercial LLC.

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• EMA approval · 2022-02-25
  New medicine for rare type of eye cancer

  The EMA announces a new medicine addressing a rare eye cancer, marking an important regulatory milestone for an orphan indication.

• FDA approval · 2022-01-25
  FDA Approved: KIMMTRAK — Original Application (Immunocore Commercial LLC)

  FDA approved KIMMTRAK (tebentafusp) in an original application for adults with unresectable or metastatic uveal melanoma, marking the first …