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Janssen's Darzalex Faspro Wins FDA Approval In Combination With Pomalidomide, Dexamethasone For Multiple Myeloma

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  • The FDA has approved Janssen Biotech Inc's, a unit of Johnson & Johnson (NYSE: JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) for multiple myeloma after first or subsequent relapse.

  • Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20, Halozyme Therapeutics Inc's (NASDAQ: HALO) Enhanze drug delivery technology.

  • The Company for drug comes in combination with pomalidomide and dexamethasone (Pd) to treat 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 in the treatment of multiple myeloma.

  • The approval is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival.

  • Price Action: HALO shares are up 1.43% at $46.15 during the premarket session on the last check Monday.

  • Related content: Benzinga's Full FDA Calendar.

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