New Immunotherapy For Resistant Multiple Myeloma Receives FDA Approval

Mark Wildgust Global Medical Affairs Head for Hematology The Janssen Pharmaceutical Companies of Johnson & Johnson

Mr. Wildgust Interview with:
Mark Wildgust
Global Medical Affairs Head for Hematology
The Janssen Pharmaceutical Companies of Johnson & Johnson

This week, the U.S. Food and Drug Administration (FDA) approved first-in-class immunotherapy DARZALEX™ (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma (MM) who have received at least three prior lines of therapy.

You can find the FDA news release here.

MedicalResearch: What is the background for this announcement? What is Multiple Myeloma?

Response: DARZALEX gives people who have limited or no remaining treatment options and are facing a difficult situation a new chance. We are excited about how DARZALEX may help these patients.

Multiple myeloma is a highly complex disease and remains incurable, with almost all patients relapsing or becoming resistant to therapy. Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow. Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.

MedicalResearch: What is DARZALEX (daratumumab) and how does it differ from traditional chemotherapy?

Response: DARZALEX is a first-in-class immunotherapy for certain multiple myeloma patients who have failed current standards of care and have limited treatment options. It is the first human anti-CD38 monoclonal antibody approved anywhere in the world and the first immunotherapy approved for multiple myeloma.

MedicalResearch: Can you tell us a little about the FDA’s accelerated approval program and why DARZALEX was approved under this track?

Why do patients have to fail three prior treatments before being prescribed this medication?

Response: DARZALEX received Breakthrough Therapy Designation from the U.S. FDA based on its potential for use in patients with a very high unmet medical need. The approval of DARZALEX comes just two months after the Biologics License Application was accepted for Priority Review by the FDA in September 2015 and almost four months ahead of its March 9, 2016 PDUFA (Prescription Drug User Fee Act) date. The FDA grants Priority Review to investigational therapies that if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

The approval for patients who have received at least three prior lines of therapy was based on the Phase 2 MMY2002 study, which showed treatment with single-agent DARZALEX resulted in an overall response rate of 29.2 percent in patients who received a median of five prior lines of therapy, including a PI and an immunomodulatory agent. We are continuing to evaluate DARZALEX for additional future indications and at this time five Phase 3 registration studies with daratumumab in relapsed and frontline settings are currently ongoing.

MedicalResearch: What are the main side effects?

Response: Overall, DARZALEX has an acceptable adverse event profile. The warnings and precautions for DARZALEX include infusion reactions, interference with serological testing and interference with determination of complete response. The most frequently reported adverse reactions (incidence ≥20 percent) were: fatigue, nausea, back pain, pyrexia, cough and upper respiratory tract infection.

MedicalResearch: Is DARZALEX potentially beneficial for any other hematologic malignancies?

Response: DARZALEX is a remarkable medicine. We have a comprehensive clinical trial program with five Phase 3 studies across a range of treatment settings in multiple myeloma. Additional studies are ongoing or planned to assess its potential in other malignant diseases on which CD38 is expressed, such as non-Hodgkin lymphoma among other hematologic malignancies.

MedicalResearch: What other therapeutics in this category are in the Janssen pipeline?

Response: Janssen is exploring therapeutics across a wide array of oncologic conditions, including  hematologic malignancies, prostate, colorectal and lung cancer. In hematologic malignancies, our approved products include IMBRUVICA, SYLVANT, DACOGEN (and VELCADE, for which we have commercial rights outside the US).  In addition, our marketed oncology products also include ZYTIGA, YONDELIS, DOXIL (sold as CAELYX outside the US) and PROCRIT (sold as EPREX outside the US).  Our pipeline includes a number of compounds in all stages of development, including a number of immuno-oncology agents; in addition, we have a large, active discovery program and a number of research collaborations.  Some of our pipeline compounds are ARN-509, which is being investigated in prostate cancer; imetelstat, CSL-362 and MGD-011, which are being investigated in hematologic malignancies; JNJ-809, which is being investigated as a prostate cancer vaccine; JNJ-757, which is being investigated as a lung cancer vaccine; and JNJ-493, which is being studied for urothelial cancer and lung cancer. A good source for information on our pipeline is the investor relations section of


FDA approves Darzalex for patients with previously treated multiple myeloma

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Mark Wildgust (2015). New Immunotherapy For Resistant Multiple Myeloma Receives FDA Approval 

Last Updated on November 19, 2015 by Marie Benz MD FAAD