EC Approves TEPKINLY Plus R2 for Follicular Lymphoma
EC approves TEPKINLY R2 follicular lymphoma combination for adults with relapsed or refractory disease. AbbVie said on 6 July 2026 that the bispecific-plus-R2 regimen is the first of its kind authorised in Europe for second-line FL, backed by Phase 3 EPCORE FL-1.
Contents9 sections
Key Takeaways
- EC authorised TEPKINLY + lenalidomide + rituximab for adult R/R follicular lymphoma.
- EPCORE FL-1: 79% reduction in progression or death risk versus R2 alone (HR 0.21).
- Complete response 74% with the combination versus 43% with R2.
- Serious ARs in 44%; CRS and infections remain key monitoring points.
TEPKINLY + R2 EU approval at a glance
| Field | Detail |
|---|---|
| Product | TEPKINLY (epcoritamab) + R2 |
| Companies | AbbVie; Genmab (co-development) |
| Regulator | European Commission marketing authorisation |
| Date announced | 6 July 2026 |
| Population | Adults with relapsed/refractory follicular lymphoma |
| Pivotal trial | EPCORE FL-1 (NCT05409066) |
| Key efficacy | HR 0.21 PFS/death; ORR 96%; CR 74% |
What did AbbVie announce?
AbbVie said EC marketing authorisation covers fixed-duration TEPKINLY with R2 after at least one prior line, offering a chemotherapy-free option in a disease that remains incurable for most patients. Epcoritamab is co-developed with Genmab; AbbVie leads further global commercialisation outside shared U.S./Japan responsibilities.
Source: AbbVie's 6 July PR Newswire EC approval release. EMA's earlier variation opinion path is documented on EMA's Tepkinly variation page.
What does EPCORE FL-1 add?
- Open-label Phase 3: TEPKINLY + R2 (n=243) versus R2 (n=245)
- Dual primary endpoints: PFS and ORR by Lugano criteria (IRC)
- 12 cycles of epcoritamab in 28-day cycles or until progression/toxicity
Registry details: ClinicalTrials.gov NCT05409066. AbbVie noted Lancet publication of the pivotal results in January 2026.
What should European centres prepare?
Bispecific step-up dosing, CRS observation capacity, infection prophylaxis, and immunoglobulin monitoring will shape rollout. Follicular lymphoma's high European incidence share among NHL makes second-line chemo-free regimens commercially and clinically significant, but national reimbursement clocks start only after EC authorisation lands in each system.
TEPKINLY already had EU monotherapy indications in later-line DLBCL and FL; the R2 combination expands earlier R/R FL use. Centres should update pathways carefully so monotherapy and combination labels are not conflated.
What remains uncertain?
Long-term durability beyond primary analyses, sequencing versus CAR-T or other bispecifics, and real-world CRS rates outside trial selection will define practice. Member-state funding decisions may stagger access across the EU.
Related NovaPharma coverage
- EMA Backs Etcamah for ESR1+ Breast Cancer
- CHMP July 2026: 12 New Medicines Recommended
- ESMO 2026 Preview: Madrid Oncology Catalysts
Frequently Asked Questions
What did the European Commission approve for TEPKINLY?
On 6 July 2026, AbbVie said the European Commission granted marketing authorisation for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (R2) for adult patients with relapsed or refractory follicular lymphoma. AbbVie called it the first and only bispecific-based therapy approved in Europe for FL in the second-line setting.
What did EPCORE FL-1 show?
In Phase 3 EPCORE FL-1, TEPKINLY plus R2 reduced the risk of disease progression or death by 79% versus R2 alone (HR 0.21, 95% CI 0.13–0.33, p<0.0001). Overall response was 96% versus 81%, and complete response was 74% versus 43%.
What safety issues were highlighted?
AbbVie said the safety profile was consistent with the known profiles of epcoritamab and R2. Common adverse reactions included neutropenia, infections, CRS, and cytopenias. Serious adverse reactions occurred in 44% of patients on the combination, including CRS, pneumonia, COVID-19, and febrile neutropenia in at least 5%.
Primary Sources
Regulatory catalyst tracker
Track PDUFA dates, approval milestones, and label updates for TEPKINLY.
Unlock full calendar →AbbVie pipeline snapshot
One-screen view of active programs, phases, and recent catalysts from public sources.
Investor brief
Download a one-page summary of regulatory impact and competitive context.
Explore drug hub →Entity graph
Continue Exploring
Open the drugs, companies, and topics behind this story.
This article follows our editorial standards. Report a correction via editorial contact.
Deeper reading
Industry reports & whitepapers
- La Negoziazione del Prezzo dei Farmaci Oncologici in Italia — This whitepaper analyzes the market benchmark role in negotiating oncology drug prices in Italy, hig…
- Cytological Specimens in the Molecular Era of Metastatic Melanoma — This whitepaper discusses the role of cytological specimens in diagnosing metastatic melanoma and th…