Mar 26, 01:00 AM

FDA Rejects Regeneron's Odronextamab, Setting Back Oncology Push with CD20 T-cell Engager; Regeneron Must Start Trials Before Refiling

Regeneron's blood cancer therapy, odronextamab, faces setbacks as FDA raises trial concerns, rejecting the lymphoma drug. The FDA highlights ongoing dose-finding work for the CD20 T-cell engager. Regeneron must start trials before refiling after receiving a Complete Response Letter for failure to enroll confirmatory trials prior to accelerated approval application.

#FDA #Complete Response Letter

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FierceBiotech@FierceBiotech
2 years ago
Days after Regeneron received a CRL for the blood cancer medicine odronextamab, hematology exec Andres Sirulnik, M.D., Ph.D., told Fierce Biotech that the trial is enrolling just fine—it’s just that randomization hasn’t begun. https://t.co/9mlBMYKXkO
BioCentury@BioCentury
2 years ago
FDA issues first CRL for failure to enroll confirmatory trials prior to accelerated approval application. Regeneron must start odronextamab trials before refiling. https://t.co/NIz1QFjkd8
BioPharma Dive@BioPharmaDive
2 years ago
FDA rejects Regeneron lymphoma drug, setting back company’s oncology push https://t.co/Netq52Hsg1 $REGN @ByJonGardner

FDA Rejects Regeneron's Odronextamab, Setting Back Oncology Push with CD20 T-cell Engager; Regeneron Must Start Trials Before Refiling

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