koto_feja Regeneron Pharmaceuticals ( NASDAQ: REGN ) said on Monday its bispecific antibody Ordspono (odronextamab) has been cleared by the European Commission for the treatment of relapsed/refractory follicular lymphoma and diffuse large b-cell lymphoma, after two or more lines of systemic therapy. Ordspono is Regeneron’s ( REGN ) first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting. The approval was based on data from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, including in the post-CAR-T setting.
“In clinical trials, Ordspono demonstrated remarkable complete response rates in follicular lymphoma, as well as compelling efficacy results in diffuse large B-cell lymphoma, including in the post-CAR-T setting,” said Stefano Luminari, Professor of Oncology at the University of Modena and Reggio Emilia, hematologist at the Hematology Unit of Arcispedale Sant Maria Nuova in Reggio Emilia, and a trial investigator. More on Regeneron Pharmaceuticals Regeneron: Expanded Product Base Taking Root, More Is Certainly On The Way Regeneron's Robust Pipeline And Financial Health Signal Continued Growth Regeneron Pharmaceuticals, Inc. (REGN) Q2 2024 Earnings Call Transcript Regeneron receives anticipated FDA rejection for blood cancer therapy Alvotech’s biosimilar to Regeneron’s Eylea under EU review.
