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Sesen Bio Pulls EU Application for Cancer Drug FDA Rejected

Sesen Bio has withdrawn its EU marketing authorization application for Vysyneum (oportuzumab monatox-qqrs) ― called Vicineum in the U.S. ― a week after FDA regulators denied approval for the bladder cancer drug.

The Cambridge, Mass., drugmaker said it withdrew the application for Vysyneum as a treatment for BCG-unresponsive non-muscle invasive bladder cancer because components of the European Medicines Agency’s review are “interrelated” with the FDA’s decision to issue a Complete Response Letter (CRL) over its biologics license application (BLA) for Vicineum.

In the CRL, the agency called for more clinical data and referred to manufacturing and control issues observed in a recent pre-approval inspection.

Sesen Bio said it will not seek approval of Vysyneum in Europe “until there is more clarity from the FDA on the next steps in the United States” that will enable it to better synchronize the regulatory reviews.

August 30, 2021

https://www.fdanews.com/

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