Expansion of indications for treatment of bladder cancer "first-in-class" antibody-conjugated drugs

On the 10th, Seagen and Astellas jointly announced that the US FDA approved the company’s antibody-conjugated drug (ADC) Paddev (enfortumab vedotin-ejfv) for extended indications for the treatment of at least one of the previous Therapy, but not suitable for locally advanced or metastatic urothelial cancer patients receiving cisplatin-containing chemotherapy

In 2020, approximately 580,000 people worldwide will be diagnosed with bladder cancer

Padcev is an antibody conjugate drug that conjugates anti-nectin-4 monoclonal antibody and microtubule inhibitor

The approval of the extended indications is based on the positive results obtained by Padcev in the second cohort of patients in the pivotal phase 2 clinical trial EV-201

The conversion of Padcev’s accelerated approval to full approval is based on positive data from the Phase 3 clinical trial EV-301

"For locally advanced or metastatic patients who have received immunotherapy but cannot receive cisplatin chemotherapy, Padcev is the first FDA-approved therapy

Reference materials:

[1] US FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer.