Johnson & Johnson Seeks Approval for DARZALEX FASPRO as Subcutaneous Monotherapy for High-Risk Smoldering Multiple Myeloma

Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO/DARZALEX as subcutaneous monotherapy for high-risk smoldering multiple myeloma.

Johnson & Johnson is a leading global healthcare company with a commitment to improving health and well-being worldwide. With a deep-rooted focus on innovation, the company spans multiple sectors, including pharmaceuticals, medical devices, and consumer health products. Through its divisions, such as Janssen Research and Development and Janssen Biotech, Johnson & Johnson is at the forefront of developing cutting-edge treatments for complex diseases, from cancer and immunological disorders to neurological conditions.

Their work focuses not only on treating illness but on preventing and curing diseases, offering smarter, less invasive, and more personalized healthcare solutions. By leveraging their expertise in both Innovative Medicine and MedTech, they are uniquely positioned to drive breakthrough advancements in healthcare that will shape the future of medicine and profoundly impact global health.

About Smoldering multiple myeloma

Smoldering multiple myeloma is an early precursor to active multiple myeloma, characterized by the presence of abnormal cells in the bone marrow, but without symptoms. While SMM is typically monitored until it progresses to active multiple myeloma, recent evidence suggests that high-risk patients may benefit from earlier intervention to prevent progression. If approved, DARZALEX could become the first treatment specifically indicated for high-risk SMM, potentially shifting the current treatment approach and providing a much-needed option for this patient population. Yusri Elsayed, Ph.D., Global Therapeutic Area Head for Oncology at Johnson & Johnson, emphasized that DARZALEX has already transformed the standard of care in multiple myeloma, and its potential approval for high-risk SMM could represent a significant advancement in the treatment of the disease.

Yusri Elsayed, M.D., M.H.Sc., Ph.D., is the Global Oncology Therapeutic Area Head at Johnson & Johnson, where he leads the company’s oncology pipeline, focusing on the discovery, development, and life cycle management of therapies for cancers such as hematologic malignancies, prostate cancer, and lung cancer. Under his leadership, J&J has built a comprehensive approach to oncology, integrating internal capabilities with an external innovation strategy to drive breakthroughs. He oversees a global team working across various platforms, including small molecules, biologics, immuno-oncology, and cell therapies. Yusri’s efforts have led to numerous successful oncology partnerships and significant advancements in cancer treatments.

Before his current role, Yusri served as Head of the Hematologic Malignancies Disease Area at J&J, where he helped develop several first-in-class therapies, such as IMBRUVICA (ibrutinib), DARZALEX, and CARVYKTI. These innovations earned multiple FDA Breakthrough Therapy Designations and major approvals, transforming the treatment landscape for blood cancers. Yusri joined J&J in 2005, building his career across various leadership positions, including overseeing clinical development for drugs like YONDELIS and VELCADE. Prior to joining the pharmaceutical industry, he was an Assistant Professor at the Cancer Institute of New Jersey. Yusri is board-certified in Internal Medicine, Medical Oncology, and Hematology, and holds advanced degrees from Duke University and Kyushu University in Japan.

About DARZALEX FASPRO

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 for nine multiple myeloma indications, including four for frontline treatment in newly diagnosed, transplant-eligible and ineligible patients. It is the only subcutaneous CD38-directed antibody for multiple myeloma, using Halozyme’s ENHANZE technology for enhanced delivery.

DARZALEX (daratumumab) was approved in November 2015 for eight indications, including frontline treatment for newly diagnosed patients. As the first CD38-directed antibody for multiple myeloma, it has treated over 518,000 patients worldwide. Janssen Biotech, Inc. holds exclusive rights to develop and commercialize daratumumab under a 2012 agreement with Genmab A/S.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration Reactions: DARZALEX FASPRO can cause systemic reactions, including severe or life-threatening ones, as well as local injection-site reactions. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO.

Neutropenia: DARZALEX FASPRO may worsen neutropenia caused by background therapy. Monitor blood counts and consider withholding until neutrophil recovery, especially in lower body weight patients.

Thrombocytopenia: May increase thrombocytopenia with background therapies. Monitor blood counts and consider withholding until platelet recovery.

Embryo-Fetal Toxicity: Can harm the fetus, causing immune cell depletion and decreased bone density. Advise effective contraception during treatment and for 3 months post-treatment.

Contraindication in Pregnancy: Combination with lenalidomide, thalidomide, or pomalidomide is contraindicated due to birth defect risks.

Serological Testing Interference: DARZALEX FASPRO can cause a positive indirect Coombs test, masking minor antigen detection. Inform transfusion centers and blood banks.

Complete Response Interference: DARZALEX FASPRO may interfere with serum protein electrophoresis and immunofixation tests, affecting response assessments in IgG kappa myeloma patients.

The AQUILA Study

AQUILA (NCT03301220) is a Phase 3, randomized, multicenter study evaluating DARZALEX FASPRO versus active monitoring in patients with high-risk smoldering multiple myeloma (n=390). The primary endpoint is progression-free survival, with secondary endpoints including time to progression, overall response rate, and overall survival. Patients enrolled were diagnosed with smoldering multiple myeloma within the last five years and had no prior exposure to treatments for smoldering or active multiple myeloma.

For more information, visit oncodaily.com.