MFDS Approves 'Padcepju' for Urothelial Carcinoma Treatment
The Ministry of Food and Drug Safety announced on the 10th that it has approved Padcev Injection (enfortumab vedotin), a rare drug from Korea Astellas Pharma, for the treatment of urothelial carcinoma.
Padcev is an antibody-drug conjugate (ADC) targeting the 'nectin-4' protein, which is highly expressed on the surface of urothelial carcinoma cells, and is intended for patients with locally advanced or metastatic urothelial carcinoma. It can be used to treat adult patients with locally advanced or metastatic urothelial carcinoma who have previously been treated with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy.
Padcev’s mechanism involves the antibody (enfortumab) binding to nectin-4 expressed on the cell surface, facilitating internalization into the cell, where it releases the cytotoxic agent vedotin (MMAE) that inhibits cell division, thereby inducing cancer cell death.
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The Ministry of Food and Drug Safety stated, "We will continue to do our best to ensure that treatments with confirmed safety and efficacy are supplied promptly based on regulatory science."
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