Benzinga | Jul 12, 2021 08:15AM EDT

Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO In Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO(r) (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval marks Janssen's sixth indication for DARZALEX FASPRO(r) in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

"We are delighted that Janssen received this FDA approval for DARZALEX FASPRO(r), making it the first and only FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy available in this combination," said Helen Torley, president and chief executive officer at Halozyme. "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."

DARZALEX FASPRO(r) is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE(r) drug delivery technology.

This FDA approval for DARZALEX FASPRO(r) in combination with Pd for patients with multiple myeloma after first or subsequent relapse is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival (PFS). For more information related the Phase 3 APOLLO study findings, please view Janssen's press release.