By Stephen Nakrosis
The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) said Friday it submitted an application with the U.S. Food and Drug Administration seeking approval of its new subcutaneous formulation of Darzalex, or daratumumab, for certain patients with multiple myeloma.
Janssen said the Biologics License Application was supported by data from its Phase 3 Columba study, which included 522 patients, and data from the Phase 2 Pleiades study, which included 240 patients.
"The Darzalex subcutaneous formulation showed non-inferiority to the existing IV formulation, both as a monotherapy and in combination with common background therapies, while administered with a considerably shorter infusion time. We look forward to working closely with the FDA in their review of the data supporting this regulatory application," said Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development.
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