The all-powerful FDA in the United States has granted Fast Track Designation (FTD) to Bicycle Therapeutics’ BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer.

BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC®) targeting Nectin-4 – a protein that is highly expressed in urothelial cancer (UC) and other solid tumours.

UC is the most common type of bladder cancer and if it extends through to the surrounding tissue or has spread to nearby lymph nodes or organs, the five-year survival rate is 38 per cent.

Headquartered in Cambridge, Bicycle was named this medium’s Business of the Year in September. The biotech company is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology.

CEO Kevin Lee says the Fast Track Designation represents another positive step in the development of BT8009 and adds that it “reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients.”

Lee said: “We believe this designation is a valuable component of our future clinical and regulatory strategy as we work to align with the FDA to address the pressing unmet needs of people living with urothelial cancer.”

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.

This unmet medical need is defined as providing a therapy where either none exists or providing a therapy which may prove superior to existing therapy. A clinical program that receives FTD may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval.

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

Quoted on the US technology exchange, NASDAQ, Bicycle is headquartered in Cambridge UK, with many key functions and members of its leadership team located in Lexington, Massachusetts.