US approval for Janssen’s Darzalex

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Janssen has picked up US FDA approval for Darzalex in combination with Velcade for the treatment of patients with newly diagnosed multiple myeloma who are transplant ineligible.

Darzalex is the first monoclonal antibody approved for newly diagnosed patients with this disease. Clinical trial results showed the treatment in combination with VMP reduced the risk of disease progression or death by 50% compared to treatment with VMP alone.

“This approval is significant as we now have the first antibody-based regimen for treating newly diagnosed multiple myeloma patients who are not eligible for a stem cell transplant,” said Andrzej Jakubowiak, Director of the Multiple Myeloma Program at University of Chicago Medical Centre, Chicago, Illinois and a Darzalex clinical study investigator.

“In clinical studies, patients who received treatment with daratumumab experienced a lower risk of disease progression and higher rates of response.”

The approval is supported by data from the randomised, open-label, multicenter Phase 3 ALCYONE study, recently published in the New England Journal of Medicine.

The combination reduced the risk of disease progression or death by 50%, compared to treatment with VMP alone. The median progression-free survival had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone.

This latest approval marks the fifth indication for Darzalex, the first CD38-directed antibody approved anywhere in the world and the first antibody approved for newly diagnosed patients with multiple myeloma who are transplant ineligible.