August 18, 2023
On August 18, Lantheus informed SNMMI that it has decided to discontinue production of Azedra (iobenguane I-131), its FDA-approved therapy for pheochromocytoma/paraganglioma (PPGL). Although the company will wind down its manufacturing site in New Jersey, it will continue to produce doses through early 2024 to allow current patients to complete their treatment.
The combination of limited usage and fixed costs made manufacturing and promotion of the product untenable, the company said.
“PPGL are ultra-rare tumors and amongst that patient population very few require systemic treatment,” the letter said. “Even when systemic treatment is required, AZEDRA is not always the treatment of choice due to the administrative requirements of AZEDRA, including appropriate shielding and in-patient treatment, which has limited the number of sites that offer AZEDRA to PPGL patients. While AZEDRA has made a difference in patients’ lives, physicians and patients have repeatedly sought alternative treatments, limiting the use and adoption of AZEDRA.”
According to Cancer.net, 2 to 8 people are diagnosed with pheochromocytoma or paraganglioma per million persons per year.
Patients and healthcare professionals may call 1-844-AZEDRA1 (1-844-293-3721) for support and assistance, Monday through Friday, 8:00 am–5:00 pm ET, or email info@AZEDRAServiceConnection.com.