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A New Chance for Patients With Advanced Multiple Myeloma

FDA Approves DARZALEX alt
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Today, we’re building on our unwavering commitment to transform cancer into a manageable and eventually curable disease.

Multiple myeloma is a blood cancer that affects plasma cells, a type of white blood cell. In multiple myeloma, plasma cells become cancerous and grow uncontrollably in the bone marrow. These cells form tumors in the bone and weaken the immune system. It is a rare, incurable cancer. Only half of patients survive five years after their initial diagnosis.

More than a decade ago, we began to build our heritage in multiple myeloma with the introduction of VELCADE®. But despite tremendous progress over the years in the treatment of multiple myeloma, an unmet need still remains. Unfortunately, people living with this cancer who don’t respond or relapse after treatment typically have poor prognoses and few remaining options. Janssen Oncology is committed to developing novel therapies for people living with hard-to-treat cancers, such as multiple myeloma.

DARZALEX™ (daratumumab) is a testament to this commitment. We are pleased to announce that the FDA has approved DARZALEX for patients whose multiple myeloma has relapsed, or who are no longer responding to current therapies.

With DARZALEX, we have a new immunotherapy option for U.S. patients who aren’t responding to treatment or whose cancer has progressed while on their current therapy. These patients may be facing difficult decisions regarding their further course of treatment.

DARZALEX is the first human anti-CD38 monoclonal antibody approved anywhere in the world and is our fourth compound to receive Breakthrough Therapy Designation (BTD) from the FDA. It is a new approach to treatment that kills malignant myeloma cells through multiple mechanisms of action. Its approval comes four months ahead of schedule, after being granted BTD by the FDA, a distinction which is intended to expedite the regulatory timeline for promising new medicines. DARZALEX was also approved with Phase 2 data, underscoring the urgent needs of these patients and its remarkable potential.

Today’s news is an incredibly important moment for patients living with multiple myeloma. We are committed to further research and development of this compound to understand its full potential clinical benefit for patients in need. We are working tirelessly to achieve our vision to conquer cancer, and help those who need it most.

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