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]

Core Insights - Bristol Myers Squibb (BMY) received European Commission approval for Breyanzi, expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][9] Group 1: Breyanzi Approval and Indications - The latest approval marks the fourth for Breyanzi in Europe, which is already approved for several other indications including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) [2] - Breyanzi is indicated for patients who relapsed within 12 months of first-line chemoimmunotherapy or are refractory to it, as well as for those with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of therapy [3] Group 2: Clinical Trial Results - The approval is based on the TRANSCEND NHL 001 trial results, where 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response, and 41.2% of patients maintained their response at 24 months [4][9] Group 3: Pipeline Expansion and Market Impact - Bristol Myers is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, including Revlimid and Pomalyst [5] - The company’s shares gained 3.3% following positive data from Bayer's cardiovascular candidate asundexian, which may boost investor confidence in BMY's own cardiovascular candidate, milvexian [6][8] Group 4: Discontinuation of Librexia Study - Bristol Myers and Johnson & Johnson decided to discontinue the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints, although two other studies for milvexian will continue [10][11]