Johnson & Johnson’s Darzalex
Johnson & Johnson’s (JNJ) Darzalex injection is a CD-38 surface protein–directed antibody approved for the treatment of multiple myeloma.
Today, JNJ announced that the US Food & Drug Administration (or FDA) approved Darzalex in combination with other drugs for the treatment of multiple myeloma, marking the fifth indication for which Darzalex has FDA approval.
Darzalex is a monoclonal antibody that targets and attaches to the protein CD-38 present on the surface of multiple myeloma cells.
Darzalex (daratumumab) is approved as a monotherapy for patients who have received at least three prior treatments, including immunomodulatory agents like Celgene’s (CELG) Revlimid (lenalidomide) and a proteasome inhibitor like Millennium Pharmaceuticals’ Velcade (bortezomib).
Darzalex is also approved in combination with other drugs, like Revlimid and dexamethasone or Velcade and dexamethasone, in previously treated patients with multiple myeloma.
Darzalex is also approved in combination with Celgene’s (CELG) Pomalyst (pomalidomide) and dexamethasone in previously treated patients with at least two prior therapies, including lenalidomide and a proteasome inhibitor.
FDA approval for fifth indication of Darzalex
Yesterday, the FDA approved Darzalex in combination with Velcade, Melphalan, and Prednisone (or VMP) for the treatment of newly diagnosed multiple myeloma in cases where patients are ineligible for autologous stem cell transplants. Velcade is a proteasome inhibitor, Melphalan is an alkylating agent, and Prednisone is a synthetic corticosteroid drug.
The approval was based on ALCYONE, a Phase 3 randomized, open-label, multicenter study. The study shows that the use of Darzalex in combination with VMP reduces the risk of disease progression and death by 50% compared to the VMP combination only.
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