EC Approves Label Expansion of INCY's Lymphoma Drug Minjuvi

Core Insights - Incyte (INCY) has received approval from the European Commission (EC) for a label expansion of Minjuvi (tafasitamab) to treat adult patients with relapsed or refractory follicular lymphoma (FL) in combination with Revlimid (lenalidomide) and rituximab [1][9] Approval Details - This marks the second indication for Minjuvi in the EU, as it was previously approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [2] - The latest approval is based on the inMIND study, which demonstrated significantly improved progression-free survival for patients with relapsed or refractory FL when treated with Minjuvi, Revlimid, and rituximab [3][9] - Minjuvi was generally well-tolerated, with a safety profile comparable to the combination of Revlimid and rituximab [4] Market Context - Follicular lymphoma is the most common indolent form of B-cell non-Hodgkin lymphoma, accounting for approximately 30% of NHL cases globally, with a significant unmet need for new treatment options [5] - The approval of Minjuvi introduces the first dual-targeted CD19 and CD20 immunotherapy for eligible FL patients in Europe, showing a meaningful reduction in disease progression risk [6] Company Strategy - Incyte is diversifying its portfolio beyond its lead drug Jakafi, which is a JAK1/JAK2 inhibitor, by gaining new approvals for Minjuvi and other drugs [7][10] - The company has seen strong uptake of recently approved drugs, including Pemazyre, Monjuvi, and Tabrecta, which will further enhance its revenue base [10] Financial Performance - Incyte has performed well in 2025, with shares surging 45.6% over the year, significantly outperforming the industry growth of 16.9% [11] - The company has also entered a global collaboration with Qiagen to develop a diagnostic panel for myeloproliferative neoplasms, which is expected to support its pipeline of investigational treatments [12][13]