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Johnson & Johnson (NYSE:JNJ) announced on Wednesday that the European Commission approved an injectable version of its blood cancer therapy Darzalex, developed with Halozyme Therapeutics (NASDAQ:HALO) and Genmab (GMAB) for smouldering multiple myeloma.
An asymptomatic disease, smouldering multiple myeloma affects nearly 15% of patients with newly diagnosed multiple myeloma cases, with half of those patients with the high-risk form of the disease advancing to active multiple myeloma within two years.
The approval is based on data from the company’s Phase 3 AQUILA study, in which nearly 63% of Darzalex SC-treated patients experienced a delay in disease progression to multiple myeloma or death, compared to ~41% in those in the active monitoring arm with a statistically significant effect.
“Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma,” said Jordan Schecter, Disease Area head for multiple myeloma, at J&J’s Innovative Medicine unit. “With today’s approval, Johnson & Johnson has an innovative therapy for every stage of the disease.