Cellectar Granted Orphan Drug Designation for CLR 131 to Treat Rhabdomyosarcoma

- May 10th, 2018

Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the … Continued

Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of rhabdomyosarcoma, a rare pediatric cancer.

As quoted in the press release:

“Rhabdomyosarcoma is the most common type of tissue sarcoma in children.  While initial response to treatment is generally favorable, there is an important need for new treatments, especially in children who experience relapse.” said John Friend, M.D., chief medical officer of Cellectar.  “Cellectar is committed to working closely with the FDA to fully evaluate the potential for targeted delivery of CLR 131 to address this currently unmet medical need.”

Orphan drug designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. Rhabdomyosarcoma is recognized by the FDA as an orphan disease, usually defined as a condition that affects fewer than 200,000 people nationwide.

Click here to read the full press release.

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