Core Viewpoint - GSK's Blenrep combination therapy has been voted against by the FDA's Oncologic Drugs Advisory Committee (ODAC) due to an unfavorable benefit/risk profile, indicating that the risks currently outweigh the benefits for treating relapsed or refractory multiple myeloma [1][8]. GSK's Stock Performance - Following the ODAC announcement, GSK's shares fell by 4.7% [2]. - Year-to-date, GSK's shares have increased by 7.8%, contrasting with a 0.6% decline in the industry [6]. Regulatory Context - The ODAC's opinion is significant as the FDA typically considers it in their final decision, which is expected on July 23 [3][8]. - The Blenrep combination therapy has already been approved in the UK and Japan but faces regulatory challenges in the United States [8][11]. - Regulatory applications for the Blenrep combination are under review in the EU and other countries [9]. Clinical Study Background - The biologics license application (BLA) for the Blenrep combination was based on data from the III DREAMM-7 and DREAMM-8 studies, which met their primary endpoints of progression-free survival (PFS) [7]. - However, Blenrep was previously withdrawn from the U.S. market after failing to meet the primary endpoint in the phase III DREAMM-3 study [10].

Core Viewpoint - GSK's Blenrep combination therapy has received a positive opinion from the EMA's CHMP for treating relapsed or refractory multiple myeloma, marking a significant step towards regulatory approval in Europe and the United States [1][2][3]. Group 1: Regulatory Developments - The CHMP recommended Blenrep in combination with J&J's Velcade and dexamethasone, as well as with Bristol Myers' Pomalyst and dexamethasone for adult patients who have undergone at least one prior therapy [2]. - The European Commission will review the CHMP's opinion, with a decision expected in Q3 2025 [3]. - Blenrep combinations have already been approved in the UK and Japan in April and May 2025, respectively, and are under review in China, Canada, and Switzerland [8]. Group 2: Clinical Data - Data from the III DREAMM-7 and DREAMM-8 studies indicated that Blenrep combinations resulted in statistically significant improvements in progression-free survival (PFS) and overall survival compared to standard treatments [4]. - The safety and tolerability profiles of Blenrep combinations were consistent with the known profiles of the individual agents used in the studies [4]. Group 3: Market Performance - GSK's shares have increased by 14.3% year-to-date, contrasting with a 5.5% decline in the industry [5]. - The company is also awaiting a decision from the FDA regarding the Blenrep combination therapy, expected on July 23, 2025 [7]. Group 4: Historical Context - Blenrep was previously withdrawn from the U.S. market in November 2022 after failing to meet the primary endpoint in the DREAMM-3 study, which evaluated its efficacy as a monotherapy [9]. - The company aims to reintroduce Blenrep to the market for patients with relapsed or refractory multiple myeloma following the recent positive developments [10].