Planned RP1 BLA Resubmission Following Productive Discussion with FDA Announced
“We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1,” said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. “We are encouraged by the agency’s commitment to supporting patients and U.S. innovation and look forward to working closely with the FDA to bring this important therapy to the advanced melanoma community as swiftly as possible.”
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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).