By Colin Kellaher
Genmab A/S on Thursday said a phase 3 study of the cancer drug Darzalex met its primary endpoint in the most common type of amyloidosis, a rare disease that occurs when an abnormal protein called amyloid builds up in a body's tissues and organs.
The Copenhagen biotechnology company said subcutaneous Darzalex in combination with cyclophosphamide, bortezomib and dexamethasone for patients with newly diagnosed light-chain amyloidosis met the primary endpoint of percentage of patients with hematologic complete response.
Genmab said the study was conducted by Johnson & Johnson's Janssen Biotech Inc. unit, which has an exclusive license to develop, manufacture and commercialize Darzalex under an August 2012 agreement.
Genmab said Janssen will discuss with health authorities the potential for a regulatory submission for the indication, adding that there are currently no approved treatments for the progressive disease.
Darzalex is already approved in several indications in multiple myeloma, a cancer that forms in a type of white blood cells called plasma cells and causes cancer cells to accumulate in the bone marrow.
U.S.-listed shares of Genmab were recently up 4.6% to $31.06. Johnson & Johnson shares gained 2.1% to $147.90.
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