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
Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub
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
Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma
Merus has licensed Halozyme’s proprietary ENHANZE technology to develop and commercialize subcutaneous formulations of petosemtamab
This is the first drug to receive a recommendation for this preventative indication in the European Union
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
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