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Cellectar Biosciences wins FDA Fast Track designation for multiple myeloma drug

The New Jersey company’s CLR 131 drug is designed to combat blood cell cancers as the fourth or later treatment option
Blood cells
The drug is currently being evaluated in the CLOVER-1 Phase 2 trial, which is being conducted in about US 10 cancer centers for patients with multiple myeloma and other blood cancers

Cellectar Biosciences Inc (NASDAQ:CLRB) was awarded Fast Track designation by the Food and Drug Administration on Monday for its relapse/refractory multiple myeloma drug.

The New Jersey company’s CLR 131 drug is designed to combat blood cell cancers as the fourth or later treatment option by delivering radiation directly and selectively to cancer cells.

READ: Cellectar Biosciences soars as it plans to initiate Phase 1 study in pediatric cancer patients after FDA grants exemption

The drug is currently being evaluated in the CLOVER-1 Phase 2 trial, which is being conducted in 10 US cancer centers for patients with multiple myeloma and other blood cancers. It’s also a part of two ongoing Phase 1 trials.

Earning Fast Track designation gives Cellectar more facetime with the FDA to discuss its study design and clinical programs. Treatments may also be in line for a priority review of their New Drug Application.

“Fast Track designation furthers our efforts to expeditiously develop CLR 131 as a new, innovative therapy for patients with relapse/refractory multiple myeloma,” said CEO James Caruso. “Based on data in the initial patient cohort from our ongoing CLOVER-1 trial where patients showed a 30% response rate after receiving a single 25.0 mCi/m2 dose as a seventh line of therapy on average, we are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients.”

CLR 131 earned orphan drug status from the FDA for multiple myeloma in 2014 and for neuroblastoma and rhabdomyosarcoma in 2018, giving the company a seven-year exclusive right to develop its treatment. 

Cellectar is a clinical-stage biopharmaceutical company focused on developing and bringing to market cancer treatments.

Shares rose nearly 2% Monday, and added nearly 2% more after the bell Tuesday to $2.33.

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

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