Darzalex granted another FDA approval

Johnson & Johnson’s multiple myeloma therapy Darzalex (daratumumab) has been given an additional FDA approval as a combination therapy with bortezomib, thalidomide and dexamethasone, a triple regimen used in the treatment of multiple myeloma. It is approved for newly diagnosed patients who are eligible for autologous stem cell transplant. The approval comes on the back of phase 3 CASSIOPEIA trial results, which showed that Darzalex in combination with VTD before or after ASCT resulted in deeper responses, and improved the progression-free survival rate in patients versus using just VTD on its own.
Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development, said: “The Darzalex clinical development programme has led to many important firsts, but more importantly, it has generated key insights and understanding into the biology and treatment of multiple myeloma. Today’s milestone marks the seventh FDA approval in less than four years for Darzalex, and the third for newly diagnosed patients.”