SGN-35 Receives Orphan Drug Designation
Seattle Genetics, Inc. received orphan drug designations from the U.S. Food and Drug Administration (FDA) for their investigative agent SGN-35 for the treatment of anaplastic large cell lymphoma (ALCL). The agent also has orphan drug status for the treatment of Hodgkin’s lymphoma.
SGN-35 is comprised of an anti-CD30 monoclonal antibody attached to monomethyl auristatin E (MMAE), a synthetic drug payload; the two are attached by an enzyme cleavable linker. SGN-35 releases MMAE upon internalization into cells expressing CD-30.
Plans for a Phase II trial evaluating SGN-35 in the treatment of ALCL and a pivotal trial evaluating its efficacy in Hodgkin’s lymphoma are planned for the first quarter of this year (2009).
Genomics and Circulating Tumor DNA Monitoring Identify High Recurrence Risk Early-Stage Breast Cancer
More evidence of utility of tumor genomic testing and circulating tumor DNA (ctDNA) monitoring in early-stage breast cancer to reduce breast cancer recurrence
Blenrep (belantamab mafodotin) for Multiple Myeloma
Blenrep targets BCMA in myeloma; has concerns of ocular side effects and could be a new standard of care for Relapsed/Refractory Multiple Myeloma
Daratumumab Shows Promise in High-Risk Smoldering Multiple Myeloma
Progression to active multiple myeloma delayed with daratumumab monotherapy among high-risk patients with smoldering myeloma
