Policy & Regulation
US FDA approves Janssen Biotech's DARZALEX FASPRO
18 January 2021 -

The United States Food and Drug Administration (FDA) has granted approval to United States-based Janssen Biotech Inc's DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) intended for the treatment of adult patients with newly diagnosed light chain amyloidosis, rare and serious blood disorder, it was reported on Friday.

The indication has been approved under accelerated approval based on the combination's hematologic complete response rate measure. The positive results from the phase three ANDROMEDA study that assessed DARZALEX FASPRO in combination with VCd, compared with VCd alone was the basis of approval.

The product is not intended for patients with light chain amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB, outside of controlled clinical trials.



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