Pfizer Europe MA EEIG withdrew its EU marketing authorization application for Zumrad (sasanlimab), a subcutaneous PD-1–blocking monoclonal antibody being developed with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC), according to an EMA questions and answers document.
The EMA said Pfizer withdrew the application on February 13, 2026, after the agency had evaluated the initial dossier and was assessing the company’s responses to CHMP questions.
In its provisional view at the time of withdrawal, the EMA said Zumrad could not have been authorized based on the available data. The agency cited concerns that major changes were made while the pivotal study was ongoing, and that the statistical method used to determine efficacy was also changed, which the EMA said increased the chance of concluding benefit. The EMA also questioned whether the primary effectiveness measure—assessed by investigators in a setting where “researchers and participants knew which treatment was being given”—was appropriate, and said it was unclear whether the effect size represented a meaningful patient benefit. The agency added that outcomes such as overall survival did not support the primary endpoint finding, and that adding sasanlimab to BCG resulted in more side effects, including immune-related events, plus more BCG interruptions and discontinuations.
Pfizer told the EMA it withdrew the application to allow for additional data collection and analyses to address the agency’s questions and concerns, and said there were no consequences for patients in ongoing clinical trials using Zumrad.
Trial and regulatory context
The application was supported by a main study in 1,055 adults with high-risk NMIBC who were BCG-naïve or had not received BCG within the prior two years. In the study, Zumrad plus BCG was compared with BCG alone. Sasanlimab was administered once every four weeks for up to two years, while BCG was given weekly for six weeks followed by maintenance across five cycles, the EMA said. The primary measure was time free of events including recurrence or worsening, presence of cancer cells in the bladder lining, or death from any cause; overall survival was also evaluated.
Pfizer has previously publicly disclosed positive Phase III results for sasanlimab plus BCG in high-risk NMIBC (the CREST program), including publication of CREST data in Nature Medicine, but the EMA document indicates the agency’s review focused on whether the evidence package was sufficient for authorization as filed.
From a treatment-landscape perspective, NMIBC drug development has accelerated in BCG-unresponsive disease, where the US FDA has approved multiple non-surgical options, including pembrolizumab (Keytruda) for BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS) (2020), nadofaragene firadenovec (Adstiladrin) gene therapy (2022), and nogapendekin alfa inbakicept-pmln (Anktiva) with BCG (2024).
Mechanistically, Zumrad targets the PD-1 checkpoint on T cells, aiming to prevent tumor-driven immune suppression via PD-L1/PD-L2 binding and thereby enhance anti-tumor immune activity—an approach that has reshaped systemic oncology but has faced design and endpoint challenges in earlier-stage, bladder-sparing NMIBC trials where recurrence-based measures, investigator assessment, and intravesical therapy schedules can meaningfully influence interpretability.