Core Insights - Johnson & Johnson (JNJ) has submitted a type II variation application to the European Medicines Agency (EMA) for the expanded use of Tecvayli (teclistamab) as a monotherapy for adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy [1][9] Regulatory Developments - The application is supported by data from the ongoing phase III MajesTEC-9 study, which demonstrated that Tecvayli significantly improved outcomes compared to standard-of-care regimens, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death [5][6] - Tecvayli is currently approved in Europe for patients with RRMM who have received at least three prior therapies [2][10] Financial Performance - JNJ reported global sales of Tecvayli at $670 million in 2025, reflecting a 22% year-over-year increase, driven by expansion into community settings [9][12] - Over the past year, JNJ's shares have increased by 49.6%, outperforming the industry growth of 14.3% [4]