Comments Sent to FDA Regarding Amino Acids Needed During Lu-177 DOTATATE Therapy

May 29, 2018

SNMMI, the Mayo Clinic, Washington University School of Medicine in St. Louis, and Memorial Sloan Kettering Cancer Center have jointly filed comments with the U.S. Food and Drug Administration (FDA) with recommendations that would make it easier for patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to tolerate and, therefore, benefit from lutetium-177 (177Lu) DOTATATE therapy.

To protect patients from potential negative side effects of this therapy, the amino acids arginine and lysine are recommended. Unfortunately, these proteins are not commercially available on their own; they are only offered in combination with other proteins and substances that can cause patients significant discomfort.

The submitted comments recommend regulatory changes that should make arginine and lysine easier to develop and distribute as bulk drugs. We are hoping for rapid FDA action on this request. Click here for a copy of the comments.