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FDA Clears J&J’s Darzalex Faspro for Early Multiple Myeloma Treatment

Phase 3 AQUILA study showed Darzalex Faspro significantly reduced the risk of progression to active multiple myeloma or death.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration approved Johnson & Johnson’s drug Darzalex Faspro as the first treatment for adults with high-risk smoldering multiple myeloma, a precursor to the blood cancer. The decision marks a shift toward earlier intervention in a disease that typically progresses to active multiple myeloma. The approval is based on results from the Phase 3 AQUILA trial, which compared Darzalex Faspro—a subcutaneous formulation of daratumumab combined with hyaluronidase—to stan...

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