Cardinal Health has signed on as a distributor of IRE ELiT’s Gallium-68 generators, the availability of which is expected to help reduce the shortage of such solutions and the challenges created for nuclear medical imaging due to their lack of availability.
The radiopharmaceutical giant signed on to distribute the Galli Eo generators following its FDA clearance back in late September, the approval of which makes IRE ELiT’s product the second type of Gallium-68 generator available to clinicians after that of Eckert & Ziegler.
“Until September 28, 2018, Eckert & Ziegler was the only approved 68-Ga generator for NETSPOT, a kit for the preparation of gallium 68-Ga dotatate injection, an FDA-approved radiopharmaceutical,” Wayne Boudreaux, director of Pharmacy Operations at Cardinal Health, told HCB News. “But the wait time to get one of these generators is 14-18 months, with the solution expiring after 12 months of use. This has created a widespread shortage in the industry, which includes rolling closures throughout the market. With the IRE-ELiT generator, we’re optimistic about the supply of 68-Ga increasing and the shortage improving as supply normalizes.”
Demand for 68-GA dotatate injections (NETSPOT) has grown since the approval of E&Z’s generators in 2016, with imaging providers seeking them for the treatment of adult and pediatric patients with neuroendocrine tumors, due to their patient-friendly regimen as an injection, ability to reduce imaging exams to approximately three hours, and their coverage by payors. The substance is the diagnostic half of a theranostics paring that enables tumor diagnosis on PET scans. It's companion drug, Lu-177 dotatate (Leutathera), fulfills the therapeutic part by allowing targeting of tumors.
But the long wait times for E&Z generators and their expiration in one year (or upon hitting its 400-elution limit) have forced distributors to implement self-imposed blackouts for NETSPOT doses, creating insufficient supplies and delaying procedures. While E&Z plans to expand production with the construction of a new facility, manufacturing is not slated to commence there until mid-2019.
IRE ELiT has already begun production on the first of its Galli Eo generators to move the product to market as fast as possible and help alleviate the shortage. Prior to its clearance, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) called for deployment of the IRE ELiT generators to be approved
, as one of three proposed solutions for tackling the shortage.
It also proposed placing a temporary exemption to the 400-elution limit of generators almost immediately, and for the use of cyclotron-generated gallium with an acqueous target to increase production at mostly academic sites for the next three to six months to relieve the need for a GMP-grade generator in particular locations.
Another aspect is raising awareness and educating radiopharmacies about these generators and how they can apply for the appropriate licensure status with the Nuclear Regulatory Commission and applicable state regulatory bodies to obtain and use them.
“The market is demanding quick access, but the licensing process, focused primarily on public safety, can take time to address with new technology, and timing may vary between different jurisdictions,” he said. “When regulators seek feedback from their licensed stakeholders, Cardinal Health offers its experience and expertise to encourage discussions on comprehensive and efficient regulatory procedures, with standardization and consistency across the different regulatory bodies, when possible.”
The NETSPOT scan is required for the administration of Lutathera, the only therapeutic for treating neuroendocrine tumors. The U.S. Advanced Accelerator Applications (AAA) has rapidly adopted NETSPOT, expanding the network of pharmacies distributing it and raising demand for it among imaging providers to 500 as of June 2018.
Distribution of the generators is expected to begin prior to the end of 2018.