Lantheus PNT2003 — Lutathera Lu-177 Dotatate Radioequivalent — Moves Into Final FDA Approval Window After 30-Month Regulatory Stay Expires June 2026
Lantheus's PNT2003 (lutetium Lu 177 dotatate ANDA-route radioequivalent) is positioned to enter its final FDA approval window after the 30-month regulatory stay expires in June 2026. The product would be the second SSTR2 PRRT in the US neuroendocrine tumor market alongside Novartis's Lutathera, which has held the category since 2018. The regulatory framework: PNT2003 received tentative approval March 2; PYLARIFY TruVu (piflufolastat F 18) high-throughput PSMA PET formulation approved March 6. ITM's Lu-edotreotide-177 (ITM-11) follows on a separate August 28, 2026 PDUFA, and Crinetics' CRN09682 SSTR2 non-peptide drug conjugate is in Phase 1/2 BRAVESST2 — making 2026 a defining year for the SSTR2 PRRT competitive frame.