Janssen Pharmaceuticals : Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
05/26/2021 | 08:49am EDT
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Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
Further analysis from the Phase 3 ANDROMEDA study presented at the 2021 ASCO Annual Meeting also show doubling rates of organ response with no new safety signals for the first FDA-approved treatment in a rare blood cell disorder
RARITAN, N.J., May 26, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver.1 Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003).2 These data will be featured in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on Tuesday, June 8.