FDA Grants Orphan Drug Designation To CFT7455 For Treatment of Multiple Myeloma

Release Date: 28-Sep-2021

US FDA has granted orphan drug designation to CFT7455 for the treatment of multiple myeloma.CFT7455 is an orally bioavailable MonoDACandtrade; degrader targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin’s lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma.


In June 2021, C4T initiated the Phase 1/2 clinical trial to firstly investigate safety, tolerability, and anti-tumor activity, with other objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT7455. C4T plans to enroll around 160 patients in Phase 1/2 trial.


The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.

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