Approval for 3-Iodobenzylguanidine in Japan

• October 1, 2021
• Reading time: 1 minute

Fujifilm Toyama Chemical Co., Ltd. announced on September 27 that it has received regulatory approval in Japan for the manufacture and sale of 3-Iodobenzylguanidine (MIBG), a radiopharmaceutical indicated for MIBG-positive, unresectable pheochromocytoma and paraganglioma.

Pheochromocytoma and paraganglioma are classified as rare cancers in Japan, with an estimated patient population of approximately 3,000. While the majority of these cases can be cured through surgical resection, patients with unresectable tumors have historically faced a significant unmet medical need due to the lack of effective therapeutic options.

3-Iodobenzylguanidine is already approved in Europe and the United States and is widely utilized in the management of these rare malignancies. Recognizing its high medical necessity, the Japanese Ministry of Health, Labour and Welfare (MHLW) prioritized its evaluation. Fujifilm Toyama Chemical subsequently conducted clinical trials in Japan and applied for manufacturing and marketing authorization in January 2021.

This radiopharmaceutical works by combining radioactive iodine with a substance that is specifically taken up by neuroendocrine tumor cells. The beta radiation emitted by the iodine then selectively targets and destroys the malignant cells. With this approval, nuclear medicine based on 3-Iodobenzylguanidine is expected to become a standard treatment option for patients with pheochromocytoma and paraganglioma in Japan.

Fujifilm Toyama Chemical remains committed to advancing healthcare by developing innovative therapeutics and leveraging its manufacturing infrastructure to meet the needs of patients and medical professionals.

Source: https://www.fujifilm.com/fftc/ja/news/271

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