DARZALEX available in Singapore, following approval by the Health Sciences Authority

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. These patients typically have poor survival prognosis, with median survival of approximately 8 months. 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.

"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 prognosis 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."

"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).