Progenics’ Azedra becomes first FDA-approved treatment for adrenal tumours
pharmafile | July 31, 2018 | News story | Manufacturing and Production, Sales and Marketing | Cancer, FDA, Progenics, adrenal cancer, pharma
The FDA has approved its first-ever drug for rare, unresectable tumours of the adrenal gland with its decision to authorise Progenics Pharmaceuticals’ radiotherapeutic product Azedra (iobenguane I 131) in the treatment of pheochromocytoma or paraganglioma in patients older than 12 who require systemic anticancer therapy.
Pheochromocytoma and paraganglioma are neuroendocrine cancers originating in and around the adrenal glands, and are associated with a range of dangerous conditions such as life-threatening blood pressure levels, heart failure and stroke, with a five-year survival rate of as low as just 12%.
The decision was based on Phase 2 data which demonstrated that 25% of 68 evaluable patients taking Azedra experienced a 50% or greater reduction of all antihypertensive medication for at least six months, while overall tumour response was achieved in 22% of patients.
“As the first FDA approved therapy for unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, Azedra provides a new treatment option for physicians and their patients,” said Mark Baker, Chief Executive Officer of Progenics. “Azedra has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients. We are extremely grateful to the patients, their families and the investigators who participated in Azedra’s clinical development programme. We also thank those who have contributed to the development of Azedra over many years.”
Alongside the approval came warnings over the serious side-effects which can arise as a result of Azedra use, including bone marrow problems, blood pressure elevation, renal toxicity, respiratory problems, pregnancy and fertility issues, and even other cancers.
Emily Collins, President of the Pheo Para Alliance, also added: “The FDA’s approval of Azedra is welcome news to patients with pheochromocytoma and paraganglioma, who have an extremely limited number of treatment options available to them. The drug’s Fast-Track status and Breakthrough Therapy designation by the FDA underscores the dire need for the development and expeditious review of diagnostic and therapeutic agents for pheo/para that, generally, don’t get adequate prioritization despite the growing prevalence of these and other NET cancers globally.”
Matt Fellows
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