Following the U.S. FDA approval of Pfizer’s antibody-drug conjugate (ADC) plus PD-1 inhibitor regimen for use before and after surgery in adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, Pfizer’s Chief Scientific Officer and Chief Oncology Officer shared the news on LinkedIn, highlighting the significance of the new treatment approach.
Chris Boshoff, Chief Scientific Officer and President of Research and Development at Pfizer, shared on LinkedIn:
“Today, the U.S. FDA has approved our antibody-drug conjugate (ADC) + anti-PD-1 treatment regimen for adults with muscle-invasive bladder cancer (MIBC) for use before and after surgery, regardless of cisplatin eligibility. This treatment regimen introduces a potential new standard of care for patients with MIBC, the first new regimen in over 3 decades. Based on the results from the Phase 3 EV-304 trial, this combination is now the first and only approved platinum-free regimen that could significantly reduce the risk of recurrence and meaningfully improve overall survival for adults living with MIBC. Read more here.
Today’s approval brings this option to more people with earlier-stage bladder cancer, building on our November 2025 approval for those unable to receive cisplatin chemotherapy.
Thank you to our R&D colleagues at Pfizer, our partners at Astellas and Merck, and above all, the people living with bladder cancer and their families who took part in the EV-304 trial and made this possible.”
Jeff Legos, Chief Oncology Officer at Pfizer, recently shared FDA approval based on the Phase III PATINA trial data on LinkedIn:post:
“Today marks a critical step forward for people living with muscle-invasive bladder cancer (MIBC). The U.S. FDA has approved our antibody-drug conjugate (ADC) + PD-1 inhibitor regimen for use before and after surgery, regardless of eligibility for cisplatin – bringing a new option to adults with MIBC who face a high risk of recurrence. Read more.
This builds on prior progress and introduces the first approved platinum-free regimen in this setting, with the potential to reduce recurrence and improve overall survival.
Advancements like this are the result of sustained scientific innovation and strong collaboration, and I’m grateful to our teams at Pfizer, our partners at Astellas Pharma and Merck, and the investigators, patients and families who participated in the research that led to this approval.”
Other articles about MIBC on OncoDaily.