EC approves Astellas’ Padcev for added indication
Japanese pharma major Astellas Pharma (TYO: 4503) today revealed that the European Commission has granted Marketing Authorization for Padcev (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with Keytruda (pembrolizumab, Merck & Co’s [NYSE: MRK] PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.
The approval is based on results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and signficantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.
Analysts have previously suggested the treatment could generate global revenues of up to $3 billion.
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