[Newsmp] The Ministry of Food and Drug Safety (MFDS) said it has granted the Korea Astellas’ rare drug Padcev (enfortumab vedotin-ejfv), a treatment for urothelial cancer, on Friday.
Padcev is an antibody-drug conjugate (ADC) that targets the protein Nectin-4, which is highly expressed on the surface of urothelial cancer cells.
The antibody acts like a homing signal, inducing the chemo drug, monomethyl auristatin E, directly to bladder cancer cells with a protein called Nectin-4 on them and killing them.
The approved indication is for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy.
The MFDS stated that this approval will provide new treatment options for patients with advanced or metastatic urothelial cancer.
