FDA Orphan Drug Designation for EO2463 OncoMimics™ to treat indolent non-Hodgkin lymphoma
“Receiving FDA Orphan Drug Designation is an important regulatory milestone for EO2463 and re-affirms our strong commercial potential. Today, the only option for non-symptomatic low tumor burden “watch-and-wait” iNHL patients is to go without treatment and be observed until the cancer progresses. We believe this places undue stress on patients and their families and is unacceptable; it is gratifying to see the U.S. regulatory agency recognizes that ‘watch-and-wait’ patients deserve a real treatment option like EO2463,” said Pierre Belichard, Chief Executive Officer of Enterome. “Together with the Fast Track designation granted late last year, FDA’s ODD further facilitates and validates our efforts to advance EO2463 toward registrational development in the watch-and-wait population. We are actively engaging with potential partners and investors to find the best path forward to rapidly advance EO2463 development in this indication.”
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