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DARZALEX® (daratumumab) Available in Singapore, Following Accelerated Approval by the Health Sciences Authority
A first-in-class multiple myeloma therapy with median overall survival of 20.1 months [1], which helps the immune system kill myeloma cells

SINGAPORE – Janssen, a division of Johnson & Johnson Pte Ltd announced the availability of DARZALEX® (daratumumab) in Singapore as a monotherapy for the treatment of multiple myeloma patients who have received at least three prior lines of therapy and have relapsed or become resistant to other therapies [1]. These patients typically have poor survival prognoses, with median survival of approximately 8 months [2]. DARZALEX received accelerated approval by Singapore's Health Sciences Authority (HSA) in October 2016, and is a first-in-class, fully human monoclonal antibody that helps improve median overall survival by 20.1 months [1].

The novel mechanisms of action of DARZALEX provide multiple approaches to promote myeloma cell death [3]. DARZALEX induces tumour cell death through multiple, immune-mediated mechanisms of action and immunomodulatory effects, in addition to direct tumor cell death via apoptosis, in which a series of molecular steps in a cell lead to its death [4]. This had led to the approval of DARZALEX in Singapore in approximately 10 months, 3 months ahead of expected approval.

“While uncommon, multiple myeloma cancer has seen rising incidences in Singapore and Asia. The treatment and research into multiple myeloma have progressed tremendously in the last 10 years with many new drugs approved in the US and Europe.” said Prof Chng Wee Joo, Centre Director, National University Cancer Institute, Singapore. “Over the longer term, we hope to contribute towards making such drugs more accessible to patients who need them.”

“Despite significant progress in the treatment of multiple myeloma over the past 15 years, it remains incurable and almost all patients will relapse. Hence, an urgent need remains for treatments with novel mechanisms of action that can accord long remissions,” said Dr Daryl Tan, Consultant Haematologist, Raffles Hospital. “With DARZALEX, we have a promising new biologic, which represents a new approach to treatment for certain multiple myeloma patients who may be facing difficult decisions regarding their prognoses and next course of treatment. DARZALEX has shown unprecedented efficacy as a single agent with a manageable safety profile in a heavily pre-treated patient population for whom all of the major classes of currently available medicines have failed.”

A Phase 2 clinical trial has shown that treatment with DARZALEX resulted in an overall response rate (ORR) of 31.1 percent with median overall survival (OS) being 20.1 months, and an eighteen months OS rate of 56.5 percent in patients who received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or were resistant to both a PI and an IMiD and treated with daratumumab monotherapy [1,2]. The median time to first response was one month.

“At Johnson & Johnson, we strive to bring innovative solutions to ameliorate patients’ lives. For this reason, we are so pleased to have daratumumab now available in Singapore for patient affected by hard-to-treat cancers, such as multiple myeloma,” said Dr Alessandra Baldini, Singapore Medical Affairs at J&J Singapore. “DARZALEX – the first CD38-directed monoclonal antibody – is a great example of this commitment to patients and healthcare providers alike. We will continue to study this compound as both a mono- and a combination therapy across all key stages of disease to understand its full clinical benefit for patients in need."

DARZALEX was first approved in November 2015 by the U.S. Food and Drug Administration (FDA) [5].

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow [5,6]. Refractory cancer occurs when a patient's disease is resistant to treatment or in the case of multiple myeloma, the disease progresses within 60 days of their last therapy[5]. Relapsed cancer means the disease has returned after a period of initial, partial or complete remission. Multiple myeloma accounts for approximately one percent of all cancers and 2 percent of all deaths from cancer [6]. Globally, it is estimated that 124,225 people were diagnosed, and 87,084 died from the disease in 2015 [7]. The annual mortality rate per 100,000 people from multiple myeloma in Asia has increased by 53.5 percent since 1990, an average of 2.3% a year [8]. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections [8]. Patients who relapse after treatment with standard therapies (including PIs or immunomodulatory agents) typically have poor prognoses and few remaining options [2].

References:

  1. Usmani, S et al. Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma. Available at http://www.bloodjournal.org/content/bloodjournal/128/1/37.full.pdf. Accessed May 2017.
  2. Usmani, S et al. Analysis of real-world data on overall survival in multiple myeloma patients with > 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or double refractory to a PI and an IMiD. Available at https://www.ncbi.nlm.nih.gov/pubmed/27486203. Accessed March 2017.
  3. Krejcik, J et al. Immunomodulatory Effects and Adaptive Immune Response to Daratumumab in Multiple Myeloma. Blood. 2015 126(23):3037.
  4. DARZALEX U.S. Prescribing Information, November 2015.
  5. Laubach, J et al., Management of relapsed multiple myeloma: recommendations of the International Myeloma Working Group. Leukemia. 2016;30: 1005–1017
  6. National Cancer Institute. SEER Stat Fact Sheets: Myeloma. http://seer.cancer.gov/statfacts/html/mulmy.html . Accessed February 2015.
  7. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide: Number of New Cancers in 2015. Available at http://globocan.iarc.fr/old/burden.asp?/. Accessed February 2016.
  8. HealthGrove. Multiple Myeloma in Asia. Available at http://global-disease-burden.healthgrove.com/l/40151/Multiple-Myeloma-in-Asia. Accessed March 2017.
Source: Janssen

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APBN Editorial Calendar 2017
January:
Healthcare Focus: LUNGS
February:
War on CANCER
March:
Get to Know TCM
April:
Diabetes: The Big Picture
May:
The Piece of Your Mind - Brain Health/Science
June:
Advocacies in Support of Rare Disease Patients
July:
Food Science & Technology
August:
Eye – the Window to your Soul
September:
Emerging Infectious Diseases
October:
No. 1 Killer — Heart Diseases
November:
Diseases threatening our Children
December:
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