Drug Approval | November 23, 2025
FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The company will present new data from across over 20 cancer types and multiple treatment settings at European Society for Medical Oncology Congress 2025
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
Pfizer’s total cumulative revenue from Seagen therapies is expected to reach $36 billion by 2028, according to GlobalData, a leading data and analytics company.
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab
Longer-term survival results underscoring role of KEYTRUDA (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189)
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