AbbVie’s Tepkinly (Epcoritamab) Gains the CHMP’s Positive Opinion to Treat R/R Follicular Lymphoma
Shots:
- The CHMP has granted positive opinion to Tepkinly (SC) monotx. in r/r follicular lymphoma (FL) patients treated with ≥2L of therapy, with the decision anticipated during H2’24
- The opinion was based on ORR results of P-I/II (EPCORE NHL-1) study assessing Tepkinly (SC) in adults (n=128) with r/r or progressive CD20+ mature B-NHL incl. FL post ≥2L of systemic therapy; safety profile was consistent with the pivotal EPCORE NHL-1 DLBCL cohort
- Another arm assessing a 3-step-up dosing (SUD) schedule in 86 patients to reduce CRS incidence & severity showed CRS incidence of 49% (42/86; 9% were grade 2) without grade 3 or higher events. Data was published in the Lancet Haematology
Ref: AbbVie | Image: AbbVie
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
