Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its therapies Darzalex Faspro (daratumumab and hyaluronidase-fihj) to the US Food and Drug Administration (FDA) and for the subcutaneous (SC) formulation of Darzalex (daratumumab) to the European Medicine Agency (EMA). The company is seeking new indication approval for these products to treat high-risk smouldering multiple myeloma (MM).
Daratumumab’s Unique Formulation and Delivery Technology
Daratumumab, the only CD38-directed antibody approved for subcutaneous administration in MM patients, is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), utilizing Halozyme’s Enhanze drug delivery technology. This innovative approach aims to improve the convenience of treatment for patients.
Supporting Data from AQUILA Study
The regulatory filings are supported by data from the ongoing Phase III AQUILA study (NCT03301220), which is assessing daratumumab SC as monotherapy compared to active monitoring in adult patients with high-risk smouldering MM. The study has not yet achieved progression-free survival (PFS) or median time to first treatment (TTFT) in the daratumumab SC treatment group. The median PFS for the active monitoring group was 41.5 months, and the median TTFT was 50.2 months, providing crucial insights into the treatment’s efficacy and timing.-Fineline Info & Tech
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