Imfinzi approved in the US for patients with BCG-naïve, high-risk NMIBC
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval for Imfinzi brings the first immunotherapy combination regimen to patients in the US with BCG-naïve, high-risk non-muscle-invasive bladder cancer, an early setting that builds on the positive impact Imfinzi is already having in muscle-invasive disease. The early and sustained disease-free survival benefit demonstrated by Imfinzi plus BCG in the POTOMAC trial is an important advance for patients at risk of early disease recurrence and signals a shift in the standard of care.”
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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).