Darzalex (daratumumab) Receives Positive Opinion from European CHMP for High-Risk Smoldering Multiple Myeloma Patients
According to a press release from Johnson & Johnson, "the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new indication for DARZALEX® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. If approved, daratumumab could shift the treatment paradigm by becoming the first approved therapy for this disease."
What This News Means
- It’s the First Potential Treatment for High-Risk SMM: Right now, even high-risk SMM patients are typically placed on “watch and wait” monitoring. That means no treatment is given until the disease progresses and damage to organs (like kidneys or bones) starts to happen. If approved, Darzalex® (daratumumab) would become the first approved treatment to intervene before the disease becomes active.
- It Could Cut the Risk of Progression or Death by 51%: According to results from the AQUILA phase III study, Darzalex cut the risk of progression to full-blown myeloma or death in half for people with high-risk SMM. For patients, this means a better chance at longer, healthier life, and possibly avoiding aggressive therapies later in their disease course.
- It’s Easy to Administer Because It's a Subcutaneous (SC) Injection: The treatment uses the subcutaneous (SC) version of Darzalex, which is delivered as a quick injection under the skin, rather than as a long IV infusion. This saves time and is generally easier and more comfortable for patients.
- It Could Change the Myeloma Treatment Landscape: Darzalex is already a key drug in active myeloma treatment. Now, it’s poised to expand into earlier stages of the disease, changing how doctors think about and manage myeloma from the very beginning. This treatment is a step toward a preventive, rather than reactive, approach, possibly delaying or even preventing full disease progression for many patients
Read the full Johnson & Johnson press release from the button below to learn more.