Darzalex Faspro / Darzalex SC filed with FDA and EMA for multiple myeloma who have received at least one prior line of therapy.- Halozyme Therapeutics

Halozyme Therapeutics announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as Darzalex Faspro (daratumumab and hyaluronidase-fihj) in the U.S. and as Darzalex (daratumumab) SC in the European Union (EU). The applications seek approval of the combination of Darzalex Faspro / Darzalex SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As a fixed-dose formulation, Darzalex Faspro / Darzalex SC can be administered over approximately three to five minutes under the skin, significantly less time than the intravenous (IV) formulation of Darzalex which is given over several hours. The supplemental Biologics License Application (sBLA) to the U.S. FDA and Type II variation application to the EMA are supported by positive findings from the Phase III APOLLO study (MMY3013), which met its primary endpoint of significantly longer progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma who received D-Pd compared with Pd alone.These applications are supported by positive results from the Phase III APOLLO study, which demonstrated improved significant progression-free survival in patients receiving the subcutaneous formulation of daratumumab. Full results from the Phase III APOLLO study, a collaboration between Janssen Research & Development, LLC and the European Myeloma Network (EMN), will be presented in an oral session at the upcoming American Society of Hematology (ASH) Annual Meeting on Sunday, December 6, 2020 at 3:00 p.m. ET (Abstract #412). The D-Pd regimen received approval from the U.S. FDA for the IV formulation of Darzalex in 2017 for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. This regimen for the IV formulation is not approved for use in Europe by the EMA.