Pfizer's European marketing authorization application for Zumrad (sasanlimab), a subcutaneous anti-PD-1 monoclonal antibody intended for use with Bacillus Calmette-Guérin (BCG) in BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC), was withdrawn on 13 February 2026, according to a notice from the European Medicines Agency (EMA). The agency raised concerns and had provisionally concluded that the drug could not be authorized based on the data submitted.
The EMA's Committee for Medicinal Products for Human Use (CHMP) had provisionally concluded that Zumrad could not be authorised. The agency identified several problems with the pivotal Phase III CREST trial data: major protocol changes were made while the study was ongoing, the statistical analysis method was altered in ways that increased the probability of a positive result, and the primary endpoint — event-free survival (EFS) assessed by unblinded investigators — was considered potentially susceptible to bias. The CHMP also noted that overall survival data, a key secondary endpoint, did not support the primary EFS finding. Pfizer said it withdrew the application to allow time to collect additional data and analyses to address the agency's questions.
The CREST trial itself had reported a 32% reduction in the risk of disease-related events with sasanlimab plus BCG induction and maintenance versus BCG alone, with 82.1% of patients event-free at 36 months compared with 74.8% in the control arm (hazard ratio 0.68; 95% CI 0.49–0.94; p=0.019). However, the overall survival interim analysis showed no difference between arms at a median follow-up of 40.9 months, and the rate of serious treatment-related adverse events was 17.7% in the sasanlimab plus BCG arm versus 1.4% in the control group.
The withdrawal leaves Pfizer (NYSE: PFE) without a European approval in BCG-naïve NMIBC at a moment when a competitor has moved ahead. AstraZeneca's durvalumab (Imfinzi), a PD-L1 inhibitor, received US FDA approval in May 2026 for BCG-naïve, high-risk NMIBC in combination with BCG, supported by data from the Phase III Potomac trial. Merck's pembrolizumab (Keytruda) holds approval specifically for BCG-unresponsive, high-risk disease with CIS with or without papillary tumors in patients ineligible for or declining cystectomy.