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Halozyme says EU approves new indication for Janssen’s Darzalex Faspro

Halozyme Therapeutics (HALO) announced that Janssen-Cilag International NV, a Johnson & Johnson (JNJ) company, received European Commission approval of a new indication for DARZALEX Faspro co-formulated with ENHANZE, as monotherapy for the treatment of adult patients with smouldering multiple myeloma at high-risk of developing multiple myeloma.”This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma,” said Dr. Helen Torley, President and CEO of Halozyme. “We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease.” The EC approval is supported by data from the Phase 3 AQUILA study, evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM.

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