Europe approves Janssen’s Darzalex in frontline multiple myeloma
pharmafile | September 4, 2018 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | EU, Europe, J&J, JJ, Janssen, darzalex, multiple myeloma, pharma
Janssen has revealed that its CD38-targeting biologic drug Darzalex (daratumumab) has received approval from the European Commission, authorising its use in the EU in combination with bortezomib, melphalan and prednisone (VMP) as a frontline therapy in the treatment of newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The decision was supported by Phase 3 data which demonstrated that Darzalex in combination with VMP reduced the risk of disease progression or death by 50% compared to VMP alone. Median progression-free survival (PFS) was not reached during the trial, but stands against an estimated PFS of 18.1 months in VMP alone.
“Today’s approval is extremely important for multiple myeloma patients, as providing a frontline treatment option that demonstrates a deep and durable response often provides the best chance at lasting remission,” said Dr Torben Plesner, Professor, Head of the Department of Hematology at Vejle Hospital in Denmark, and the first investigator to administer daratumumab in human trials. “It’s all the more remarkable considering it has only been ten years since the first dose of daratumumab was administered in the earliest human studies. I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.”
Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead at Janssen, added: “We are incredibly grateful to the patients and physicians who participated in the clinical programme for making this approval possible. Our mission has been to ensure daratumumab reaches as many eligible patients as possible and to prolong and improve their quality of life. This is a significant step forward.”
Darzalex has previously been approved in the region in combination with and dexamethasone, or bortezomib and dexamethasone, as a treatment for MM in adults who have received at least one prior therapy, and additionally as a monotherapy for the treatment of adult patients with relapsed and refractory forms of the condition, previously treated with a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.
Matt Fellows
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