FDA approves Lunsumio VELO™ for subcutaneous use in R/R FL
“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”
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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).