Bicycle Therapeutics' BT8009 Gets FDA Fast Track Designation To Treat Urothelial Cancer

(RTTNews) - Bicycle Therapeutics plc (BCYC) announced Wednesday that the U. S. Food and Drug Administration has granted Fast Track Designation or FTD to its BT8009 monotherapy to treat adult patients with previously treated locally advanced or metastatic urothelial cancer.

BT8009 is a potential first in class Bicycle Toxin Conjugate or BTC targeting Nectin-4, a protein that is highly expressed in urothelial cancer and other solid tumors.

FTD is intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Clinical programs conducted under FTD may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

Kevin Lee, Chief Executive Officer, said, "FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients."

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