J&J's Drugs Get CHMP Recommendations for Blood Cancer Indications

Core Insights - Johnson & Johnson (J&J) received a positive recommendation from the EMA's CHMP for label expansions of its drugs Darzalex and Imbruvica for new indications [1][8] Group 1: Darzalex - The CHMP recommended expanding Darzalex's label to treat adults with high-risk smoldering multiple myeloma (SMM) [2][4] - If approved, Darzalex will be the first therapy for this patient population, which is currently managed through active monitoring [3] - The decision is supported by data from the phase III AQUILA study, showing significant reduction in the risk of progression or death compared to active monitoring [4] - Darzalex sales increased by 20% year over year to $3.24 billion in Q1 2025, driven by market share gains [5] Group 2: Imbruvica - The CHMP also recommended Imbruvica for treating adults with previously untreated mantle cell lymphoma (MCL) eligible for autologous stem cell transplant [9][10] - If approved, Imbruvica could be the first BTK inhibitor for this indication, potentially offering long remissions without the burden of transplant [10] - The recommendation is based on the TRIANGLE study, which demonstrated improved overall survival with Imbruvica plus chemotherapy [11] - J&J markets Imbruvica in partnership with AbbVie, sharing commercial responsibilities in the U.S. and international profits [12] Group 3: Stock Performance - J&J's stock has risen nearly 4% year to date, outperforming the industry, which has seen a 3% decline [6]