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

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. “Patients with AL amyloidosis, including those with advanced organ dysfunction, often face poor outcomes, and as many as 30 percent die within the first year of diagnosis,” said Efstathios Kastritis, M.D.*, Professor of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece and study investigator. “The longer-term results from the ANDROMEDA study show sustained overall deep hematologic responses and further establish the subcutaneous formulation of daratumumab as part of a new standard of care regimen in patients...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the...
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