European Commission Approves PADCEV for Locally Advanced or Metastatic Urothelial Cancer

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The European Commission (EC) has approved PADCEV (enfortumab vedotin) as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor, according to Astellas Pharma Inc. and Seagen Inc. The European Commission’s approval is based on results from the global phase 3 EV-301 trial, which showed overall survival (OS) advantage over chemotherapy.

“The approval of enfortumab vedotin in the European Union is a significant milestone for people living with advanced urothelial cancer who have had limited treatment options and poor survival rates. We look forward to working with health authorities to ensure people living with advanced urothelial cancer can access this new treatment option as soon as possible,”

said Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Development Therapeutic Areas, Astellas.

Adult patients (n=608) with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and a PD-1/L1 inhibitor were enrolled in the EV-301 trial, which compared enfortumab vedotin to chemotherapy. Patients who received enfortumab vedotin (n=301) in the trial lived 3.9 months longer than those who got chemotherapy (n=307) at the time of the pre-specified interim analysis.[Hazard Ratio=0.70 (95 percent Confidence Interval [CI]: 0.56, 0.89), p=0.001] The median OS was 12.9 vs. 9 months, respectively [Hazard Ratio=0.70 (95 percent Confidence Interval [CI]: 0.56, 0.89], p=0.001]. Alopecia, fatigue, decreased appetite, peripheral sensory neuropathy, diarrhea, nausea, pruritus, dysgeusia, anemia, weight loss, rash maculo-papular, dry skin, vomiting, aspartate aminotransferase increased, hyperglycemia, dry eye, alanine aminotransferase increased, and rash were the most common adverse reactions with enfortumab vedotin in clinical trials.

“The EV-301 study is the first randomized trial to show improved overall survival in patients with advanced urothelial cancer who received a platinum-containing chemotherapy and an immunotherapy. This approval of enfortumab vedotin from the European Commission is an important moment for these patients and their physicians,”

said Professor Ignacio Durán, M.D., Ph.D., Hospital Universitario Marqués de Valdecilla, Spain.

The EV-301 trial’s findings will be used to support global registrations for enfortumab vedotin. The European Union (EU) the Member States, as well as Iceland, Norway, and Liechtenstein, are covered by the EC marketing authorization for enfortumab vedotin. 

The most frequent type of bladder cancer is urothelial cancer.  In 2020, an estimated 204,000 persons in Europe will be diagnosed with urothelial carcinoma, with over 67,000 dying as a result of the disease.  Enfortumab vedotin is the first antibody-drug conjugate approved for the treatment of urothelial carcinoma in the European Union.

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