Janssen has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for a new subcutaneous (SC) formulation of Darzalex (daratumumab) for the treatment of multiple myeloma.
Darzalex is currently available as a solution for intravenous (IV) infusion; the SC formulation is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) which allows for under the skin drug delivery.
The BLA was supported by data from the randomized, multicenter, open-label phase 3 COLUMBA trial which compared the SC formulation to IV administration in 522 patients with multiple myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug, or whose disease was refractory to both a PI and an immunomodulatory agent (median age of 67).
Results showed non-inferior efficacy and pharmacokinetics for the SC formulation of daratumumab compared with IV administration with an overall response rate of 41% vs 37%, respectively (95% CI, 1.11 [0.89-1.37]; P <.0001); progression-free survival was also comparable between both formulations (hazard ratio [HR] 0.99; 95% CI, 0.78-1.26; P< .9258). The median duration for each SC injection was 5 minutes compared with >3 hours with IV infusions.
“The Darzalex subcutaneous formulation showed non-inferiority to the existing IV formulation, both as a monotherapy and in combination with common background therapies, while administered with a considerably shorter infusion time,” said Craig Tendler, MD, VP, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “We look forward to working closely with the FDA in their review of the data supporting this regulatory application.”
Darzalex, a CD38-directed cytolytic antibody, is approved for the treatment of multiple myeloma as combination therapy with bortezomib, melphalan, and prednisone or lenalidomide and dexamethasone, in newly-diagnosed patients who are ineligible for autologous stem cell transplant; as combination therapy with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in patients who have received ≥1 prior therapy; as combination therapy with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI); or as monotherapy in patients who have received ≥3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
For more information visit darzalex.com.