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Cellectar's therapy adds US FDA orphan-drug tag for rare cancer type

Cellectar Biosciences Inc. said the U.S. Food and Drug Administration granted an orphan drug designation to its experimental therapy for a rare type of cancer known as lymphoplasmacytic lymphoma.

The Florham Park, N.J.-based biotech is developing CLR 131 for treating multiple types of cancers including lymphoplasmacytic lymphoma, also known as Waldenstrom macroglobulinemia.

In lymphoplasmacytic lymphoma, cancer cells make large amounts of an abnormal protein called macroglobulin.

The U.S. regulator awards orphan-drug designations to medicines that treat diseases that affect fewer than 200,000 people in the country. Cellectar is eligible to receive seven-year market exclusivity with increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the new drug application user fee.

Cellectar is conducting a phase 2 study, dubbed as Clover-1, to evaluate CLR 131 in patients with B-cell blood cancers that came back or were unresponsive to treatments.

The FDA has previously granted CLR 131 orphan-drug and rare pediatric disease designations to treat neuroblastoma — a cancer of the nerve cells, rhabdomyosarcoma and Ewing's sarcoma. Rhabdomyosarcoma is cancer that forms in the soft tissues of certain muscles, while Ewing's sarcoma is a type of cancer that forms in bone or soft tissue.

Additionally, the drug received orphan drug and rare pediatric disease tags from the U.S. regulator for the treatment of osteosarcoma, a rare form of bone cancer in children that typically affects the large bones of the arm or leg.

CRL 131 has also received orphan-drug designation from the FDA and the European Commission for the treatment of multiple myeloma.

The drug is a combination of radioactive iodine with a compound that can identify and deliver radiation directly into the cancer cells to induce cell death.

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