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The approval marks the ninth indication for Darzalex Faspro, the only subcutaneous anti-CD38 monoclonal antibody approved to treat multiple myeloma across multiple treatment regimens.
Janssen’s profitable Darzalex Faspro (daratumumab and hyaluronidase-fihj) garnered a new indication from the FDA.
The agency approved the medication, in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone (Kd), to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Darzalex Faspro, which had net trade sales of $841 million in the United States in the third quarter of 2021, is already approved for several multiple myeloma indications, as well as AL amyloidosis, which is caused by the accumulation of an immunoglobulin light chain protein.
The new approval of subcutaneous daratumumab in combination with Kd will “help clinicians address unmet patient needs by reducing the administration time from hours to just minutes, and reducing the frequency of infusion-related reactions, as compared with the intravenous daratumumab formulation in combination with Kd,” Ajai Chari, M.D., professor of medicine and director of clinical research in the Multiple Myeloma Program at Mount Sinai Cancer Clinical Trials Office, said in a news release.
The approval is based on updated data, presented at the 2020 American Society of Hematology Annual Meeting. At a median duration of follow-up of 9.2 months, the study met its primary endpoint, demonstrating an overall response rate of 84.8% with Darzalex Faspro-Kd.
The study also demonstrated that 77.3% of patients achieved a very good partial response or better.
In July, the FDA okayed the sixth indication for Darzalex Faspro to treat patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
FDA cleared Darzalex Faspro in combination with pomalidomide and dexamethasone (Pd) for the treatment, based on findings from the phase 3 APOLLO study, which were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and were recently published in The Lancet Oncology.
“Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma,” Meletios A. Dimopoulos, M.D., principal study investigator and professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, said in a Janssen statement.