FDA Grants Final Approval to BRAVNETSA for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors – Lantheus

Lantheus Holdings  announced that the FDA  has granted final approval for Bravnetsa (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to Lutathera (lutetium Lu 177 dotatate).

Bravnetsa is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

“As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to Lutathera approved in the United States, Bravnetsa’s approval marks an important milestone for Lantheus as we continue to expand our radiopharmaceutical portfolio, bringing additional treatment options to people living with GEP-NETs. We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.” – Mary Anne Heino, Executive Chairperson and CEO, Lantheus.

Bravnetsa was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway. As part of this review, Bravnetsa is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, Lutathera.

“For more than 70 years, Lantheus has helped define what’s possible in radiopharmaceuticals. As the first radioligand therapy approved through the ANDA pathway, Bravnetsa represents a breakthrough for our industry and opens a new regulatory pathway for innovation. Innovation comes in many forms, and this approval reflects Lantheus’ ability to apply our deep radiopharmaceutical expertise in navigating the ANDA process and gives clinicians another FDA-approved option to support treatment decisions based on each patient’s needs.” – Ludger Dinkelborg, PhD, Head of Research and Development, Lantheus.