EC Approves Label Expansion of INCY's Lymphoma Drug Minjuvi
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December 18, 2025 — 09:30 am EST Written by Zacks Equity Research for Zacks-> Incyte INCY announced that the European Commission (EC) has approved a label expansion of Minjuvi (tafasitamab).The drug, in combination with Revlimid (lenalidomide) and rituximab, is now indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) following at least one line of systemic therapy.The is the second indication for which Minjuvi has received approval in the EU. The drug is already approved in the EU in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).The latest EC approval is based on data from the late-stage inMIND study evaluating the efficacy and safety of Minjuvi in combination with rituximab and Revlimid as a treatment for patients with relapsed or refractory FL.Data from this registrational study showed that patients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and Revlimid.Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to Revlimid in combination with rituximab.The approval succeeds positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) in November 2025.FL is the most common indolent form of B-cell non-Hodgkin lymphoma (NHL), accounting for roughly 30% of NHL cases worldwide. The disease is generally considered incurable, with many patients relapsing after initial treatment and facing a progressively poorer prognosis with each subsequent recurrence. Despite therapeutic advances, a substantial unmet need remains for new options to treat relapsed or refractory FL, which affects an estimated 2-4 per 100,000 people in Western countries.The latest approval of Minjuvi in combination with Revlimid and rituximab in the EU marks a significant advancement, introducing the first dual-targeted CD19 and CD20 immunotherapy for eligible patients with FL in Europe and demonstrating a meaningful reduction in the risk of disease progression, including in those with high-risk disease.We note that Monjuvi is also approved by the FDA in combination with Revlimid and rituximab for the treatment of adult patients with relapsed or refractory FL. In addition, Monjuvi received accelerated approval in the United States in combination with Revlimid for the treatment of adult patients with relapsed or refractory DLBCL.Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. Incyte earns royalties from NVS on sales outside the country.However, the company is looking to diversify its revenue base due to its heavy dependence on Jakafi.The uptake of recently approved drugs (Pemazyre, Monjuvi and Tabrecta) has been strong. Additional label expansions of these drugs will further diversify its portfolio.Incyte has put up a stellar performance in 2025 on the back of better-than-expected quarterly results, and positive pipeline and regulatory updates.INCY’s shares have surged 45.6% in a year compared with the industry’s growth of 16.9%.Image Source: Zacks Investment ResearchEarlier in the year, INCY’s new global collaboration with Qiagen QGEN also impressed investors.The collaboration is aimed at developing a novel diagnostic panel to support INCY’s pipeline of investigational treatments for myeloproliferative neoplasms, a group of rare blood cancers.Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing technology to detect clinically relevant gene alterations in hematological malignancies. QIAGEN will also assist with regulatory submissions and market access efforts in the United States, the EU and certain Asia-Pacific regions.INCY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want to be tipped off early to our 10 top picks for the entirety of 2026? History suggests their performance could be sensational. From 2012 (when our Director of Research Sheraz Mian assumed responsibility for the portfolio) through November, 2025, the Zacks Top 10 Stocks gained +2,530.8%, more than QUADRUPLING the S&P 500’s +570.3%. Now Sheraz is combing through 4,400 companies to handpick the best 10 tickers to buy and hold in 2026. Don’t miss your chance to get in on these stocks when they’re released on January 5. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportNovartis AG (NVS) : Free Stock Analysis ReportQIAGEN N.V. (QGEN) : Free Stock Analysis ReportIncyte Corporation (INCY) : Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchThe views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.This data feed is not available at this time.