FDA Issues Tentative Approval of Emerging Radioligand for Gastroenteropancreatic Neuroendocrine Tumors

The Food and Drug Administration (FDA) has granted tentative approval of the radioligand PNT2003, which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).¹

A radioequivalent of Lutathera (¹⁷⁷Lu dotatate, Novartis), PNT2003 can be utilized to treat patients with foregut, hindgut and midgut neuroendocrine tumors, according to Lantheus, the developer of PNT2003.

A 2017 phase 3 trial of ¹⁷⁷Lu dotatate revealed a nearly 55 percent increase in progression-free survival (PFS) for patients with metastatic midgut neuroendocrine tumors in comparison to a control group (65.2 percent vs. 10.3 percent).²

Lantheus noted that full FDA approval for PNT2003 is subject to a 30-month stay, due to a Hatch-Waxman patent litigation, which is currently slated to expire in June 2026.

“As the first radioequivalent to LUTATHERA to receive FDA tentative approval, PNT2003 marks an important step forward in Lantheus’ work to advance treatment options for patients with GEP-NETs. This milestone comes at a time when advances in imaging and evolving clinical guidelines are enabling the identification of more patients who stand to benefit from targeted radiopharmaceutical therapies. … (We) look forward to making PNT2003 available to patients pending final FDA approval,” said Mary Anne Heino, the chief executive officer of Lantheus.

References

1. Lantheus. Lantheus receives FDA tentative approval for lutetium Lu 177 dotatate (PNT2003), radioequivalent to LUTATHERA®. GlobeNewswire. Available at: https://www.globenewswire.com/news-release/2026/03/02/3247398/0/en/Lantheus-Receives-FDA-Tentative-Approval-for-Lutetium-Lu-177-Dotatate-PNT2003-Radioequivalent-to-LUTATHERA.html . Published March 2, 2026. Accessed March 2, 2026.

2. Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of ¹⁷⁷Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135.