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 full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab
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