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Padcev (enfortumab vedotin) approved in EU for advanced urothelial carcinoma

 Last Update: 2022-05-21
 Source: Internet
 Author: User

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Biopharmaceutical companies Astellas and Seagen today announced that the European Commission has approved Padcev (enfortumab vedotin) as a monotherapy for adults with locally advanced or metastatic urothelial carcinoma

Urothelial carcinoma is a cancer that originates in the urinary tract, which includes the bladder, ureters, urethra, and kidneys

Ahsan Arozullah, head of Astellas' developmental therapeutic area, said the approval represents "an important milestone for patients with advanced urothelial cancer who have limited treatment options and poor survival rates

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The EU approval was supported by data from the Phase III EV-301 trial, in which a total of 608 patients were randomized; 301 were assigned to receive Padcev (enfortumab vedotin) and 307 to receive chemotherapy

The results showed that patients who received Padcev (enfortumab vedotin) had a median overall survival (OS) of 12.

Figure 1.

The FDA expanded Padcev's indication last year to include the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy

FDA

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