Janssen and Genmab's Darzalex (daratumumab) Receives Conditional Approval from EMA for Multiple Myeloma
First CD38-Targeting Antibody Approved in Europe
Darzalex (daratumumab), co-developed by Janssen Biotech and Genmab, has received Conditional Marketing Authorisation from the European Medicines Agency (EMA). This marks a significant milestone as the first CD38-targeting human monoclonal antibody approved for the treatment of multiple myeloma. It offers a new targeted therapy option for patients who have relapsed or are refractory to existing treatments, addressing a significant unmet medical need. This approval allows for rapid commercial expansion in the European market.
Efficacy Demonstrated Through Phase 2 and Phase 1/2 Data
This approval is based on the efficacy demonstrated in the Phase 2 SIRIUS trial and the Phase 1/2 GEN501 trial, which evaluated daratumumab as a single agent. In the SIRIUS trial, daratumumab achieved an overall response rate (ORR) of 29.2%, demonstrating potent anti-cancer activity even in patients with multiple myeloma refractory to multiple therapies. In the GEN501 trial, the 16mg/kg dose arm achieved an ORR of 36% and a median progression-free survival (PFS) of 5.6 months. The pooled analysis of both trials revealed a median overall survival (OS) of 19.9 months, a significant improvement compared to existing standard treatments.
Market Positioning and Differentiation from Competing Drugs
Darzalex operates through a distinct mechanism of action, inducing apoptosis in CD38-overexpressing cells, which is different from existing proteasome inhibitors (PI) or immunomodulatory drugs (IMiD). This allows it to induce excellent direct anti-cancer effects and immune-mediated cell death, even in patients who are refractory to existing treatments. Compared to competing drugs such as Takeda's Ninlaro (ixazomib) and Amgen's Kyprolis (carfilzomib), Darzalex has demonstrated superior efficacy as a single agent, establishing a differentiated position. In the future, as clinical trials expand to include various combination therapies with existing standard treatments, it is likely to further solidify its market dominance.
Commercial Value and the Path to a $10 Billion Blockbuster
The European launch of Darzalex has provided Janssen and Genmab with a platform to drive rapid growth in the multiple myeloma treatment market. The drug generated global sales of $572 million in 2016, shortly after its launch, and has since grown to $11.67 billion in 2024 and $14.351 billion in 2025, establishing itself as a major blockbuster. Although the high price of the drug initially led to challenges in negotiating prices with European health authorities and securing reimbursement, its overwhelming clinical benefits allowed it to quickly penetrate the market. This is considered one of the most successful examples of a biotech licensing deal that has translated research and development into commercial success.
Janssen and Genmab's Darzalex received EMA conditional approval based on integrated data from the Phase 2 SIRIUS and Phase 1/2 GEN501 trials, demonstrating an overall response rate of 31.1%, and emerged as the first CD38-targeting antibody therapy in the multiple myeloma market. This has enabled it to capture the patient population refractory to existing standard treatments such as Revlimid, and secure a unique market position against competing drugs such as Amgen's Kyprolis and BMS/AbbVie's Empliciti. This approval marks a key turning point in Darzalex's growth trajectory, with the potential to generate significant milestone payments under the $1.1 billion global licensing agreement signed between the two companies in 2012 (including a $55 million upfront payment and royalties ranging from 12% to 20%). With annual sales exceeding $14 billion in 2025, Darzalex is poised to become a major blockbuster drug. From a research and industry perspective, the approval of daratumumab as a single-agent therapy provides a clinical foundation for future expansion into combination therapies and the first-line treatment market, maximizing the long-term pipeline value of the drug.
Source: EMA (ema)