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Halozyme Therapeutics Announces Janssen Has Submitted US And EU Applications Seeking Approval Of DARZALEX FASPRO

SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration

· 11/12/2020 08:17

SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration (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 3 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.1

"We are pleased that Janssen has submitted applications in both the US and EU to expand the label for the subcutaneous form of DARZALEX® utilizing our ENHANZE® technology," said Dr. Helen Torley, president and chief executive officer. "We look forward to the subcutaneous forms of DARZALEX® becoming available for a broader group of patients with multiple myeloma, offering them the potential for reduced administration time from hours to minutes compared with the IV formulation."

These applications are supported by positive results from the Phase 3 APOLLO study, which demonstrated improved significant progression-free survival in patients receiving the subcutaneous formulation of daratumumab.2

Full results from the Phase 3 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.