Monday, June 26, 2023
Jubilant Draximage Inc., doing business as Jubilant Radiopharma™, a subsidiary of Jubilant Pharma, and Evergreen Theragnostics, Inc., a radiopharmaceutical company focused on enhancing options for cancer patients, have announced a new agreement. The collaboration involves Jubilant's radiopharmacy business division, which operates the second largest nuclear medicine pharmacy network in the United States.
The agreement entails Jubilant's radiopharmacy business preparing, selling, and distributing doses of OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection) to positron emission tomography (PET) customers throughout the country. However, it's important to note that OCTEVY™ is still pending approval from the United States Food & Drug Administration (FDA), with the expected approval timeframe in the second half of 2023.
OCTEVY™ is currently undergoing evaluation by the FDA as a potential radioactive diagnostic agent for use with PET in localizing neuroendocrine tumors (NETs) that exhibit somatostatin receptor positivity. Once approved, OCTEVY™ could offer healthcare providers a new imaging option to assist in managing NETs in both adult and pediatric patients.
According to the agreement, Jubilant will be responsible for reconstituting, radiolabeling, and delivering OCTEVY™ doses to hospitals and independent PET imaging centers across the United States, following regulatory approval.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a diverse group of cancers originating from neuroendocrine cells, which transmit messages between the nervous system and endocrine system. NETs can present with varying symptoms due to the presence of neuroendocrine cells in multiple organs, making diagnosis challenging. Although the incidence of NETs is relatively low, it has been increasing, partly due to improved detection methods. PET scans are commonly used to localize and stage NETs, aiding healthcare providers in determining the most appropriate treatment strategies.
OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection) is currently under evaluation by the FDA as a radioactive diagnostic agent intended for use with positron emission tomography (PET) to localize somatostatin receptor-positive neuroendocrine tumors (NETs) in both adult and pediatric patients. Radiopharmacies will receive OCTEVY™ as a two-vial kit, enabling the direct preparation of Ga 68 DOTATOC injection using an on-site generator. It is important to note that OCTEVY™ has not yet received FDA approval and is not currently available for sale in the United States.