Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.
Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.
Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.