European Commission approves RYBREVANT (amivantamab) + chemo for adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy
“The approval of amivantamab in combination with chemotherapy addresses a major unmet need for those whose disease has progressed following treatment with an EGFR TKI and who, until now, have faced limited treatment options,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “This milestone further reinforces the critical role of precision medicine in driving enhanced outcomes for patients living with lung cancer.”
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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).