Enfortumab vedotin is the first antibody drug conjugate approved in Singapore for la/mUC patients who received a prior platinum-containing chemotherapy and a PD-1/L1 inhibitor.

SINGAPORE  - 6 June 2022 - Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that PADCEV™ (enfortumab vedotin) has been approved by the Health Sciences Authority of Singapore as monotherapy for the treatment of adult patients with locally advanced (LA) or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The Singapore approval follows the earlier European Commission (EC) approval of PADCEV™ on 13 April 2022. Singapore is among the first two countries in Asia Pacific (alongside Japan) to receive market authorisation. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.

"This is a significant milestone for Singapore. The approval of enfortumab vedotin provides new treatment options for patients living with advanced urothelial cancer and have had limited treatment options and low survival rates. We look forward to working with other health authorities across the region to ensure more patients living with advanced urothelial cancer can access this new treatment option as soon as possible," said Verma, Vivek, Head of Medical Affairs International Markets & Greater China, Astellas.

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

Urothelial cancer is the most common type of bladder cancer, accounting for 90 per cent of all bladder cancer cases[2]. In the Asia Pacific region, an estimated 130,000 people were diagnosed with urothelial cancer in 2021, and more than 65,000 have died as a result of the disease[3]. Urothelial cancer is also found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra[4].

PADCEV™ has received marketing authorization in the United States, Japan, Canada, the European Union (EU), Israel, The United Kingdom, Switzerland, Brazil and Singapore. (*).