Accelerated assessment

The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). The drug is approved in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal […]

A potential new treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) has been validated for scientific evaluation under an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).  Pharming’s investigational drug leniolisib, a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, will be evaluated as a therapy in adolescents and adults 12 years or […]