On June 23, 2023 Jubilant Draximage Inc. (dba, Jubilant Radiopharma), a Jubilant Pharma Company, through it’s Radiopharmacy business division which maintains the second largest nuclear medicine pharmacy network in the US, and Evergreen Theragnostics, Inc., a radiopharmaceutical company focused on improving the available options for cancer patients, reported a new agreement for Jubilant’s radiopharmacy business to prepare, sell, and distribute doses of OCTEVY (Kit for Preparation of Ga 68 DOTATOC Injection) to positron emission tomography (PET) customers across the US (Press release, Jubilant Radiopharma, JUN 23, 2023, View Source [SID1234632878]). OCTEVYTM is pending approval by the United States Food & Drug Administration (FDA), which is expected in 2H 2023.
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OCTEVY is currently under evaluation by the FDA as a potential radioactive diagnostic agent indicated for use with PET for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. If approved, OCTEVY can provide a new imaging option for healthcare providers to aid in the management of NETs in their patients.
Under the terms of the agreement, upon regulatory approval, Jubilant will reconstitute, radiolabel, and deliver OCTEVY doses ordered by hospitals and independent PET imaging centers in the United States.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a diverse set of cancers that originate in neuroendocrine cells, which are cells that carry messages from the nervous system to the endocrine system. Because neuroendocrine cells are located in many organs, NETs are often heterogeneous in their symptoms and therefore difficult to diagnose. The incidence of NETs are low, but are increasing, likely in part due to increased diagnosis of the disease. Once a patient has been identified as having a NET, they will often undergo a PET scan to localize and state the cancer, which will help the care team identify the best course of treatment.
About OCTEVY
OCTEVY (Kit for Preparation of Ga 68 DOTATOC Injection), is currently under evaluation by FDA as a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. OCTEVY is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 DOTATOC injection with the eluate of Gallium from an on-site generator at the radiopharmacy. OCTEVY is not currently approved by the FDA and is not yet available for sale in the United States.