We have generic somatostatin analogues, generic targeted therapy e.g. Afinitor, and I guess it was only a matter of time until we got generic PRRT (Radioligand Therapy) e.g. generic Lutetium Lu177 dotatate. This news begins that process which is also based on a clinical trial which took place in Canada (195 participants) and which now appears to be complete. The announcement comes from US but if this is realised, you can expect it to be available in many other countries and continents where there is a market. This may even drive down prices and/or increase availability.
“PNT2003: The First Radioequivalent to Lutathera, Cleared in Principle”
So what does that mean? The FDA tentative approval confirms that the agency has completed its technical review and that PNT2003 meets all statutory requirements for approval under the Federal Food, Drug, and Cosmetics Act. However, marketing clearance remains blocked pending the expiration of a 30-month regulatory stay, a standard Hatch-Waxman mechanism triggered by patent litigation with the reference listed drug holder. That stay is scheduled to expire in June 2026, at which point Lantheus will seek final approval and is positioned to launch commercially. The distinction matters to investors and oncology practices tracking access timelines: the FDA’s scientific review is done, the drug is cleared on merit, and the delay is purely legal, not clinical or regulatory. Once the stay expires, Lantheus can proceed immediately to final approval and launch. Read more here.
This forecast approval appears to come with a ‘theranostic’ approach in that Lantheus also submitted it’s own generic SSTR PET known as LNTH-2501 or Ga 68 edotreotide, a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumours (NETs). The extension and revised target Prescription Drug User Free Act (PDUFA) goal date of June 29, 2026, will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501. My take on this is that the SSTR PET approval is being timed to coincide with the rubber stamp of PNT2003 as explained above. Read more here.
Original Post follows
The FDA has accepted Lantheus Holdings, Inc’s abbreviated new drug application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), which is a generic formulation of lutetium Lu 177 dotatate (Lutathera). The treatment is indicated for adults with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.1
Following the most recent revision to the FDA’s online paragraph IV database listings, Lantheus stated in a press release that it will be the first applicant to file a substantially complete ANDA to the FDA for Lutetium Lu 177 dotatate to include paragraph IV certification under the provisions of the Hatch-Waxman Act. Should the FDA approve the ANDA, Lutetium Lu 177 Dotatate will be eligible for 180 days of generic marketing exclusivity in the United States, according to Lantheus.
If the FDA approves the abbreviated new drug application for Lutetium Lu 177 Dotatate, the drug will be eligible for 180 days of generic marketing exclusivity in the United States for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors.
Lantheus was granted worldwide rights to exclusively license POINT Biopharma’s PNT2002 and PNT2003 drug candidates in November 2022 after reaching several collaboration agreements.
“These exclusive license agreements and collaborations leverage the complementary strengths of both companies in radiopharmaceutical oncology and enhance the potential impact that these compelling therapeutic candidates could provide to patients,” said Mary Anne Heino, Lantheus president and CEO, in a press release.
Per the agreement, POINT led the completion of the ongoing OZM-067 trial (NCT02743741) in Canada and Lantheus completed regulatory filings to the FDA in the United States.
The prospective, single-arm, multicenter OZM-067 trial is analyzing the safety and efficacy of lutetium-177 octreotate (PNT2003) in 195 patients with somatostatin receptor–positive NETs identified by gallium-68 dotatate.
“This collaboration also immediately unlocks value for POINT, reduces the need for dilutive fundraising, and enables us to focus on our pipeline of next generation radioligands, which could be transformative for the field of precision oncology,” McCann said. “We are excited to continue developing and scaling our manufacturing capabilities to support the PNT2002 and PNT2003 launches and continue development of PNT2004, our pan-cancer FAP-α program, which is currently in Phase I, and PNT2001, our actinium-225 next-generation PSMA program which is expected to begin Phase I in 2023.
References
- Lantheus Announces Three-Month Extension of PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
- Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate (PNT2003), Radioequivalent to LUTATHERA®
- Lantheus announces acceptance of its first-to-file ANDA for generic Lutathera (Lutetium Lu 177 Dotatate). News release. Lantheus. January 11, 2024. Accessed January 11, 2024.
- Lantheus and POINT Biopharma announce strategies collaboration and exclusive license agreements for the commercialization of PNT2002 & PNT2003. News release. Lantheus. November 14, 2022.
All you need to know about PRRT
Most in the NET community will know it as “Peptide Receptor Radionuclide Therapy (PRRT).
All you need to know about SSTR PET
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Ronny
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Thank you for this timely post. I am facing a new therapy (not sure what yet) as Afinitor is not agreeing with me. It was very helpful to read about PRRT and I’m very excited about Histotripsy! Again thank you for the info enabling me to ask informed questions when discussing my treatment.
Best to both you and Mrs. A!