Neuroendocrine Tumors

• EMA approval · 2026-08-28
  EMA Authorised: SomaKit TOC (edotreotide) — Novartis Europharm Limited

  EMA authorised SomaKit TOC (edotreotide) for neuroendocrine tumors and radionuclide imaging; orphan medicine status.

• EMA approval · 2026-08-14
  EMA Authorised: Lutathera (lutetium (177Lu) oxodotreotide) — Novartis Europharm Limited

  Lutetium-177 Lu oxodotreotide (Lutathera) has been authorised by EMA for neuroendocrine tumors, designated as an orphan medicine.

• EMA approval · 2026-07-21
  EMA Authorised: Lutathera (lutetium (177Lu) oxodotreotide) — Novartis Europharm Limited

  EMA authorised Lutathera (lutetium-177 Lu oxodotreotide) for neuroendocrine tumors; orphan medicine designation.

• EMA approval · 2026-03-25
  EMA Authorised: SomaKit TOC (edotreotide) — Advanced Accelerator Applications

  EMA authorised SomaKit TOC (edotreotide) for imaging neuroendocrine tumors; the product is designated an orphan medicine and is associated w…

• EMA approval · 2025-09-15
  EMA Authorised: Locametz (gozetotide) — Novartis Europharm Limited

  EMA authorised Locametz (gozetotide) for radionuclide imaging, with Novartis Europharm Limited as the marketing authorisation holder; decisi…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-03-23
  FDA Approved: LOCAMETZ — Original Application (Advanced Accelerator Applications USA, Inc)

  The FDA approved LOCAMETZ as an original application for a kit that prepares Gallium-68 gozetotide for PET imaging.

• FDA approval · 2022-02-09
  FDA Approved: OCTREOSCAN — Supplemental Application (Curium US LLC)

  FDA documents a supplemental approval application for OCTREOSCAN (Indium-111 pentetreotide) submitted by Curium US LLC.

• FDA approval · 2021-12-22
  FDA Approved: NETSPOT — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  The FDA approved a supplemental application for NETSPOT (68Ga-DOTATATE) submitted by Advanced Accelerator Applications USA, Inc.

• FDA approval · 2021-12-17
  FDA Approved: ILLUCCIX — Original Application (Telix Pharmaceuticals (US) Inc.)

  FDA approves the original application for ILLUCCIX, a kit to prepare Gallium-68 gozetotide injection for PET imaging of neuroendocrine tumor…

• FDA approval · 2021-06-22
  FDA Approved: NETSPOT — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approved a supplemental application for NETSPOT (68Ga-DOTATATE) from Advanced Accelerator Applications USA, Inc., resulting in changes t…

• FDA approval · 2020-05-28
  FDA Approved: LUTATHERA — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approved a supplemental application for Lutathera (lutetium-177 dotatate) submitted by Advanced Accelerator Applications USA, Inc.

• FDA approval · 2019-08-21
  FDA Approved: GA-68-DOTATOC — Original Application (UIHC P E T Imaging Center)

  FDA approved GA-68-DOTATOC (edotreotide gallium-68) in an Original Application for PET imaging of somatostatin receptor-positive neuroendocr…

• FDA approval · 2018-04-12
  FDA Approved: NETSPOT — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  The FDA approved a supplemental application for NETSPOT (68Ga-DOTATATE) submitted by Advanced Accelerator Applications USA, Inc.

• CLINICAL_TRIALS approval · 2018-04-09
  Clinical Trial Update: EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx

  Marketing approval has been granted for Lutathera (lutetium-177 dotatate) for somatostatin receptor‑positive neuroendocrine tumors, includin…

• FDA approval · 2017-01-20
  FDA Approved: NETSPOT — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approved a supplemental application for NETSPOT (68Ga-DOTATATE) submitted by Advanced Accelerator Applications USA, Inc.

• FDA approval · 2016-09-02
  FDA Approved: NETSPOT — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approved a supplemental application for NETSPOT (68Ga-DOTATATE), a radiopharmaceutical imaging agent for somatostatin receptor–positive …

• FDA approval · 2011-02-10
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Mylan Institutional LLC)

  The FDA approved the original ANDA for octreotide acetate from Mylan Institutional LLC. This marks the generic approval for this product.