U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
First and only treatment regimen for adults with MIBC, regardless of cisplatin eligibility, representing a platinum-free potential standard of care
Broadened approval supported by Phase 3 EV-304 data showing a nearly 50% reduction in the risk of tumor recurrence, progression or death, and a 35% reduction in the risk of death, versus standard of care in cisplatin-eligible patients
This is at the end of Pfizer’s press release ….
“ BOXED WARNING: SERIOUS SKIN REACTIONS
PADCEV (enfortumab vedotin-ejfv) can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.”
h/t A Deplorable Neanderthal