Tuesday, April 16, 2024

Gastroenteropancreatic Neuroendocrine Tumors Treatment Lutathera Application Accepted by FDA

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The U.S. Food and Drug Administration (FDA) has recently accepted Lantheus Holdings, Inc.’s Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), marking a significant advancement in the availability of generic formulations for lutetium Lu 177 dotatate (Lutathera), a treatment indicated for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), encompassing foregut, midgut, and hindgut NETs.

Lantheus, in a recent press release, indicated that it is the first applicant to file a substantially complete ANDA for Lutetium Lu 177 dotatate, including paragraph IV certification as per the provisions of the Hatch-Waxman Act. This certification could potentially grant Lantheus 180 days of generic marketing exclusivity in the United States, upon FDA approval of the ANDA. This development is pivotal as it positions Lantheus at the forefront of providing a generic version of gastroenteropancreatic neuroendocrine tumors treatment in the U.S. market.

The journey towards this submission saw Lantheus secure worldwide rights to exclusively license POINT Biopharma’s PNT2002 and PNT2003 drug candidates. This agreement, formalized in November 2022, resulted from multiple collaboration agreements. Mary Anne Heino, President and CEO of Lantheus, underscored the significance of these collaborations, highlighting how they leverage the complementary strengths of both companies in the field of radiopharmaceutical oncology. This partnership aims to enhance the therapeutic potential of these candidates, thereby providing substantial benefits to patients.

Strategic Collaboration for Advancing Lutathera in Gastroenteropancreatic Neuroendocrine Tumors Treatment

The collaboration has been structured to utilize the strengths of each party efficiently. POINT led the completion of the ongoing OZM-067 trial (NCT02743741) in Canada, while Lantheus took charge of the necessary regulatory filings to the FDA in the United States. Joe McCann, Ph.D., CEO of POINT Biopharma, lauded Lantheus for its commercial leadership in radiopharmaceuticals, noting their experience with complex products and established commercialization track record for drugs like Pylarify and Azedra.

The OZM-067 trial, a prospective, single-arm, multicenter study, focuses on assessing the safety and efficacy of lutetium-177 octreotate (PNT2003) in 195 patients with somatostatin receptor-positive NETs, as identified by gallium-68 dotatate. Enrollment criteria for this trial were stringent, including evidence of disease progression, an ECOG performance status of two or less, a Ki67 index of 30% or less, and adequate laboratory and liver function tests. Patients with significant bone metastases were also considered, provided they were subject to careful monitoring. The primary measure for the trial was progression-free survival at 12 months post-therapy.

The diagnosis and treatment of gastroenteropancreatic neuroendocrine tumors often require a multidisciplinary approach, involving a range of specialists. The successful management of these conditions relies heavily on a combination of biochemical, radiologic, and surgical methods.

Gastroenteropancreatic Neuroendocrine Tumors

A Milestone in Cancer Treatment and Medical Innovation

McCann also emphasized the value this collaboration brings to POINT, reducing the need for dilutive fundraising and allowing the company to focus on developing its pipeline of next-generation radioligands. These include transformative candidates for precision oncology, such as PNT2004, their pan-cancer FAP-α program currently in Phase I, and PNT2001, an actinium-225 next-generation PSMA program expected to begin Phase I in 2023.

In conclusion, the FDA’s acceptance of Lantheus Holdings’ ANDA for a generic version of Lutetium Lu 177 Dotatate is a landmark development in gastroenteropancreatic neuroendocrine tumors treatment. It not only paves the way for more accessible treatments for patients with gastroenteropancreatic neuroendocrine tumors but also demonstrates the effectiveness of strategic collaborations in advancing medical innovation. This progression signifies a crucial step forward in making advanced cancer treatments more widely available, potentially benefiting a significant number of patients while continuing to drive advancements in the field of radiopharmaceutical oncology.


Resource: Pharmexec, January 11, 2024

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