HORSHAM, Pa. - The U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX FASPRO™ can be administered over approximately three to five minutes, significantly less time than DARZALEX®, which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO™ demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX® in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO™ compared to intravenous DARZALEX® (13 percent vs. 34 percent, respectively).
The Janssen Pharmaceutical Companies of Johnson & Johnson has been granted the approval.
"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."
The approval is based on data from the Phase 3 COLUMBA (MMY3012) and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPRO™ as monotherapy compared to those taking intravenous DARZALEX® as monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO™ versus intravenous DARZALEX® (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEX FASPRO™ as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX® and DARZALEX FASPRO™ were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO™ in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2
"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEX FASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."
"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."
DARZALEX FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE® drug delivery technology]. DARZALEX FASPRO™ will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX® formulation will also remain available as an option for patients and their physicians.
DARZALEX FASPRO™ is approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
The U.S. FDA approval of DARZALEX FASPRO™ marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.