Catalent Indiana, LLC

FDA Issues Second Complete Response Letter for Odronextamab in Relapsed/Refractory Follicular Lymphoma

- The FDA has issued a second complete response letter (CRL) for odronextamab's biologics license application, this time related to observations from an FDA site inspection at Catalent Indiana, LLC manufacturing facility. - Updated ELM-2 trial data with 28.3 months median follow-up demonstrate sustained efficacy with 80.5% overall response rate and 74.2% complete response rate in heavily pretreated follicular lymphoma patients. - The bispecific antibody received European Union approval in August 2024 for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma after at least 2 prior therapies. - Safety profile remains consistent with previous reports, dominated by manageable cytokine release syndrome and infection-related adverse events requiring careful patient monitoring and prophylaxis.