Cellectar Biosciences Inc.'s experimental blood cancer treatment has been awarded the orphan-drug designation by the European Commission.
The drug, CLR 131, is being tested in phase 1 and 2 studies for therapy-resistant multiple myeloma, a type of blood cancer that forms in white blood cells known as plasma cells, that has returned. CLR 131 had already received U.S. Food and Drug Administration fast-track and orphan-drug designations for multiple myeloma and other cancers, Florham Park, N.J.-based Cellectar said in its Sept. 24 press release.
The European Commission's orphan-drug designation program allows for reduced regulatory filing fees, protocol assistance from the European Medicines Agency and a potential expedited review, according to Cellectar. Should the drug candidate be approved under the program, it will receive 10 years of market exclusivity.
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