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FDA Grants Rare Pediatric Disease Designation to CLR 131 in Treatment of Osteosarcoma

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The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to CLR 131 for the treatment of osteosarcoma. CLR 131 has received Rare Pediatric Disease designation in four pediatric cancers: neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and now osteosarcoma.

The FDA grants Rare Pediatric Disease designation for diseases that primarily affect children from birth to 18 years old and fewer than 200,000 persons in the United States. This program is intended to encourage the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

About Osteosarcoma
Osteosarcoma derives from bone-forming mesenchymal cells and is the most commonly diagnosed primary bone malignancy among children and adolescents. The incidence is about 4.4 cases per 1 million per year in children younger than 24 years, according to research by Mirabello et al. Although there is a 70% cure rate among patients with localized disease, 5-year overall survival rates are approximately 20% among patients who develop metastatic disease, according to Saraf et al. Additionally, among patients who experience disease progression or recurrence, survival is less than 30%, according to Chou et al.

About CLR 131
CLR 131 is an investigational radioiodinated phospholipid drug-conjugate therapy that exploits the tumor-targeting properties of a phospholipid ether and its analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a phase II clinical study in relapsed or refractory multiple myeloma and a range of B-cell malignancies as well as a phase Ib clinical study in patients with relapse or refractory multiple myeloma exploring fractionated dosing.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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