The FDA Oncologic Drugs Advisory Committee July 17 recommended against approval of a Blenrep-based regimen for the treatment of relapsed or refractory multiple myeloma, citing unacceptable rates of ocular toxicity and overall poor tolerability of the drug.
FDA granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients (1 year of age and older) with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
