AbbVie’s Tepkinly Wins EC Approval with 79% Risk Cut; HDV ETF Jumps 15%
ABBV•EC granted marketing authorisation for AbbVie’s Tepkinly with lenalidomide and rituximab after Phase III data showed a 79% risk reduction and 74% response rate in 243 lymphoma patients. AbbVie also benefits from inclusion in the HDV dividend ETF that has outperformed the S&P 500 with a 15% year-to-date gain.
1. European Commission Approval
The European Commission granted marketing authorisation for AbbVie’s Tepkinly (epcoritamab) in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma in adults. This decision follows regulatory review of the fixed-duration regimen and marks a key approval in the EU for the co-developed bispecific antibody.
2. Phase III EPCORE FL-1 Trial Data
The pivotal Phase III EPCORE FL-1 trial compared the Tepkinly plus R² regimen against R² alone, enrolling 243 patients per arm. Results showed a 79% reduction in disease progression or death risk, a 96% overall response rate versus 81%, and complete responses in 74% versus 43% of patients, with safety profiles consistent with known treatments.
3. ETF Inclusion and Market Impact
AbbVie’s inclusion in the iShares Core High Dividend ETF (HDV)—which has returned 15% year-to-date versus the S&P 500’s 9%—underscores institutional interest in its dividend profile. Exposure alongside energy and healthcare names has driven ETF outperformance and may support additional buying pressure on AbbVie shares.
