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FDA Accepts New Drug Application From Lantheus Holdings for Generic Lutathera in GEP-NETs


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.

Image credit: THITIPORN | stock.adobe.com

Image credit: THITIPORN | stock.adobe.com

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.

Lantheus was granted worldwide rights to exclusively license POINT Biopharma’s PNT2002 and PNT2003 drug candidates in November 2022 after reaching several collaboration agreements.2

“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.2

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.2

“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. Their experience with these complex products and established footprint in commercializing Pylarify and Azedra makes them an ideal collaborator for these programs,” said Joe McCann, PhD, CEO of POINT Biopharma, in the release.1

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. Enrollment criteria included evidence of disease progression demonstrated by imaging within six months prior to study enrollment, ECOG performance status of two or less, Ki67 index of 30% or less, and adequate laboratory and liver function tests within two weeks before enrollment.3

Patients with bone metastases with more than 25% bone marrow involvement were eligible for enrollment based on careful monitoring of hematological reserve. Patients eligible for enrollment were administered four cycles of Lu-dotatate with a primary outcome measure of progression-free survival at 12 months from the last dose of therapy.3

Appropriate diagnosis and treatment of GEP-NETs frequently includes collaboration between specialists across multiple disciplines with specific biochemical, radiologic, and surgical treatment methods.4

“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.”2


1. 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. https://www.globenewswire.com/news-release/2024/01/11/2807869/0/en/Lantheus-Announces-Acceptance-of-its-First-to-File-ANDA-for-Generic-LUTATHERA-Lutetium-Lu-177-Dotatate.html

2. Lantheus and POINT Biopharma announce strategies collaboration and exclusive license agreements for the commercialization of PNT2002 & PNT2003. News release. Lantheus. November 14, 2022. Accessed January 11, 2024. https://www.globenewswire.com/news-release/2022/11/14/2554779/0/en/Lantheus-and-POINT-Biopharma-Announce-Strategic-Collaboration-and-Exclusive-License-Agreements-for-the-Commercialization-of-PNT2002-PNT2003.html

3. Lu-Dotatate treatment in patients with 68Ga-Dotatate somatostatin receptor positive neuroendocrine tumors. ClinicalTrials.gov. Updated July 25, 2023. Accessed January 11, 2024. https://clinicaltrials.gov/study/NCT02743741

4. Díez M, Teulé A, Salazar R. Gastroenteropancreatic neuroendocrine tumors: diagnosis and treatment. Ann Gastroenterol. 2013;26(1):29-36. PMID: 24714698; PMCID: PMC3959515. Accessed January 11, 2024.

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