FDA Accepts Filing of Abbreviated NDA for Generic Lutathera in GEP-NETs

The FDA has accepted the filing of an abbreviated new drug application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), a generic version of lutetium Lu 177 dotatate (Lutathera) indicated for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs in adults.¹

Under the most recent revision to the FDA’s online paragraph IV database listings, the applicant, Lantheus believes that they will be the first to have submitted a substantially complete ANDA for Lutetium Lu 177 dotatate containing a paragraph IV certification under the provisions of the Hatch-Waxman Act.

If the ANDA is approved by the FDA, the company believes it will be eligible for 180 days of generic marketing exclusivity in the United States.

In November 2022, Lantheus and POINT Biopharma announced several collaboration agreements, which granted Lantheus worldwide rights to exclusively license POINT’s PNT2002 and PNT2003 drug candidates.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,” Mary Anne Heino, president and chief executive officer (CEO) of Lantheus, said in a news release.

“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,” Joe McCann, PhD, CEO of POINT Biopharma, added.

According to the agreement, POINT was tasked with leading the completion of the ongoing University Health Network–sponsored OZM-067 trial (NCT02743741) in Canada, while Lantheus completed the regulatory filings in the US.²

The prospective, single-arm, multicenter trial is evaluating the safety and efficacy of lutetium-177 octreotate (PNT2003) in 195 patients with somatostatin receptor–positive NETs identified by gallium-68 dotatate. To be eligible for enrollment, patients must have evidence of disease progression demonstrated by imaging within 6 months prior to study enrollment, an ECOG performance status of 2 or less, a Ki67 index of 30% or less, and adequate laboratory and liver function tests within 2 weeks prior to enrollment.³

Notably, patients with extensive bone metastases with more than 25% bone marrow involvement were eligible for the study, contingent on careful monitoring of hematological reserve.

Eligible patients will receive 4 cycles of Lu-dotatate. The primary outcome measure will be progression-free survival at 12 months from the last dose of therapy.³

“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 1, and PNT2001, our actinium-225 next-generation PSMA program which is expected to begin phase 1 in 2023.”²

References

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