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EMA accepts Astellas/Seagen’s enfortumab vedotin sales authorization application (MAA)

 Last Update: 2021-04-13
 Source: Internet
 Author: User

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European Medicines Management Agency (EMA) has accepted Astellas and Seagen of enfortumab vedotin the marketing authorization application (MAA).

management

EMA will review enfortumab vedotin in an accelerated evaluation method, which means that the Committee on Medicines for Human Use (CHMP) can shorten the evaluation time.

MAA’s approval is based on the Phase III EV-301 trial, which evaluated the effectiveness and safety of enfortumab vedotin compared to chemotherapy in the treatment of locally advanced or metastatic urothelial cancer.

The results showed that compared with the chemotherapy group, patients in the enfortumab vedotin group had longer overall survival, with an average overall survival of 12.

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