The FDA approved Johnson & Johnson's filing for Darzalex Faspro (daratumumab/hyaluronidase-fihj), for use in combination with bortezomib, cyclophosphamide and dexamethasone (VCd), to treat adults with newly diagnosed light-chain (AL) amyloidosis, the company announced Friday. The drug, a subcutaneous formulation of the CD38-directed antibody Darzalex (daratumumab), was first cleared in the US last year as a treatment for multiple myeloma.
Jan van de Winkel, chief executive of Johnson & Johnson's partner Genmab, said "AL amyloidosis is a devastating and potentially fatal blood disorder that, until now, did not have any FDA-approved therapies." He called the decision a "critical step forward" for this patient population. Darzalex Faspro, which utilises Halozyme's ENHANZE drug-delivery technology, is not indicated for the treatment of patients with AL amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB.
The accelerated FDA approval was based on data from the randomised Phase III ANDROMEDA study, comparing Darzalex Faspro plus VCd versus VCd alone in 388 patients with newly diagnosed AL amyloidosis. Genmab noted that among patients who received Darzalex Faspro in combination with VCd, 72% had baseline cardiac involvement, with serious cardiac disorders occurring in 16% of participants.
Findings presented at the American Society of Hematology (ASH) conference last month showed that the primary outcome measure of haematologic complete response was achieved in 53% of patients treated with Darzalex Faspro plus VCd, which was significantly higher than the 18% seen for VCd alone. Results also consistently favoured the Darzalex Faspro-containing regimen across various measures of deep haematological response, including delaying the time to major organ deterioration progression-free survival. Meanwhile, Johnson & Johnson said Darzalex Faspro plus VCd had an "acceptable" safety profile, consistent with that previously seen for each of the agents alone.
In 2012, Genmab granted Johnson & Johnson an exclusive worldwide license to develop, manufacture and commercialise Darzalex. At its most recent earnings call, Johnson & Johnson said Darzalex sales were up 43.8% in the third quarter to $1.1 billion, boosted by "solid uptake" of the subcutaneous formulation, which has also been submitted for EU approval in the AL amyloidosis indication.
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