Cellectis Gets Orphan Designation for Drug Used in Cancer Treatment

By Stephen Nakrosis

Cellectis said a drug it developed is used as part of a treatment regimen for certain leukemia patients received orphan drug designation from the Food and Drug Administration.

CLLS52, or alemtuzumab, is an investigational medicine product used as part of the lymphodepletion regimen associated with UCART22, a type of CAR T-cell therapy, Cellectis said on Thursday.

Chief Medical Officer Mark Frattini said its BALLI-01 study demonstrated the importance of adding alemtuzumab to the lymphodepletion regimen.

Orphan designation is given to drugs intended to treat a condition affecting fewer than 200,000 people in the U.S., or which won't be profitable within seven years following approval by the FDA, the agency said on its website. Benefits of gaining orphan drug designation include tax credits for qualified clinical trials, exemption from user fees and the potential for seven years of market exclusivity after approval, the FDA said.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

August 01, 2024 18:02 ET (22:02 GMT)

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