Genmab A/S (NASDAQ:GMAB) has announced that Jansen Biotech Inc., its licensing partners, has submitted a supplemental Biologics Licence Application to the FDA for approval of DARZALEX FASPRO™ in the treatment of light-chain amyloidosis (AL). DARZALEX FASPRO™ is a subcutaneous daratumumab formulation used in combination with cyclophosphamide, bortezomib, and dexamethasone in treating AL amyloidosis.
Genmab eligible of $8 million milestone payment with sBLA submission
The FDA will review the sBLA application under Project Orbis and the Real-Time Oncology Review pilot program. Genmab granted Janssen in August 2021 an exclusive global license for the development, manufacture, and commercialization of daratumumab. Following the application’s submission, an $8 million milestone payment has been triggered, payable to Genmab. However, these milestone payments associated with the sBLA submission will not impact the 2020 guidance of Genmab.
Jan van de Winkel, the CEO of Genmab, said that they are delighted with the submission of the sBLA for DARZALEX FASPRO™ in treating AL Amyloidosis, which will be reviewed under Project Orbis and RTOR pilot program. Jan added that they are optimistic that this will result in having the first approved therapy for patients with AL Amyloidosis. The company submitted the data based on Phase III ANDROMEDA (AMY3001) trial data. The study evaluated daratumumab and hyaluronidase-fihj combined with VCD in treating patients with early diagnosed AL amyloidosis.
DARZALEX a potential treatment for multiple myeloma
The Phase III study evaluated 388 patients with freshly diagnosed AL Amyloidosis. They randomized the patients to receive hyaluronidase-fihj or daratumumab in combination with a proteasome inhibitor (bortezomib), chemotherapy (cyclophosphamide), and a corticosteroid (dexamethasone or using VCD treatment alone. The study’s primary endpoint was the proportion of patients that attained a complete hematologic response.
DARZALEX is an important therapy in multiple myeloma treatment. The intravenous infusion of DARZALEX has been indicated for treatment in combination with dexamethasone and carfilzomib in the US for treatment of refractory/relapsed multiple myeloma patients that have received 1-3 previous lines of therapy. It is also used in combination with dexamethasone, thalidomide, and bortezomib in treating newly diagnosed multiple myeloma patients needing stem cell transplant.