FDA Oncology Announcements

Anti-nectin-4 ADC × Genitourinary × Clear all

5 Announcements

FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer

Trial: KEYNOTE-905
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody, Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer

Trial: EV-302
Drugs: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

Trial: EV-103
Drugs: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

Trial: EV-201
Drug: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer

Trial: EV-201
Drug: PADCEV (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary