AbbVie ABBV announced that the European Commission (EC) approved the expanded use of Tepkinly (epcoritamab) for the relapsed or refractory follicular lymphoma (R/R FL) indication. The EC approved the drug in combination with rituximab and lenalidomide (Tepkinly+R2) for adult patients with R/R FL after at least one line of systemic therapy.
The approval represents Tepkinly's third indication in the European Union (EU) and marks the first EU approval of a bispecific-based, chemotherapy-free therapy for second-line relapsed or refractory follicular lymphoma.
To remind investors, ABBV markets epcoritamab under the brand name Epkinly in the United States and Japan, and as Tepkinly in the EU.
Tepkinly is already approved as monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma and R/R FL after two or more lines of systemic therapy in the EU.
The FDA approved Epkinly in combination with rituximab and lenalidomide for a similar indication in the United States in November 2025.
Year to date, ABBV shares have rallied 11.5% compared with the industry’s 13.8% growth.
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ABBV's Tepkinly Combo EU Nod Backed by Phase III Study
The EU approval is based on data from the pivotal phase III EPCORE FL-1 study, which demonstrated that Tepkinly+R2 significantly improved outcomes compared to the standard-of-care R2 alone in second-line patients with R/R FL. The combination reduced the risks of disease progression or death by 79% and achieved higher overall and complete response rates versus R2 alone. Its safety profile was consistent with the known profiles of the previous individual therapies, with no new safety signals identified.
The most common adverse events included neutropenia, rash, infections, fatigue, diarrhea, COVID-19 and cytokine release syndrome, while serious adverse events occurred in 44% of patients.
Follicular lymphoma is a slow-growing type of B-cell non-Hodgkin lymphoma and the second most common subtype of the disease. Although treatment can induce remission, FL remains incurable, with many patients experiencing relapses and requiring additional therapies over time. The disease is more prevalent in European populations than in non-European populations.
AbbVie has partnered with Genmab GMAB to jointly develop epcoritamab under the companies' oncology collaboration agreement. While both companies share commercialization rights in the United States and Japan, AbbVie is responsible for commercialization in other global markets. AbbVie and Genmab continue to advance their global development and regulatory expansion while evaluating the therapy as a monotherapy and in combination regimens across multiple hematologic malignancies through several late-stage clinical studies.
ABBV’s Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore IMCR and Amarin Corporation AMRN, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents per share. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 12.5% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
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AbbVie Inc. (ABBV): Free Stock Analysis Report
Amarin Corporation PLC (AMRN): Free Stock Analysis Report
Genmab A/S Sponsored ADR (GMAB): Free Stock Analysis Report
Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).