Vivek Subbiah: FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
“It’s Friday and we have another FDA approval.
FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma.
Afamitresgene autoleucel is also the first FDA-approved T cell receptor (TCR) gene therapy.
The product is an autologous T cell immunotherapy composed of a patient’s own T cells.
T cells are modified to express a TCR that targets MAGE-A4, an antigen (substance that normally triggers your immune system) expressed by cancer cells in synovial sarcoma.
The product is administered as a SINGLE intravenous dose.
Huge congrats to the trials team, patients and all their caregivers who made it happen in a rare disease.
Key: HLA = human leukocyte antigen; SPEAR = Specific Peptide Enhanced Affinity Receptor; TCR = T-cell receptor ”
Vivek Subbiah is the Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute (USA). He is the former Executive Director of Oncology Research and former Associate Professor in the Department of Investigational Cancer Therapeutics at the MD Anderson Cancer
He focuses on translational cancer research and the design and implementation of early-phase biomarker-driven clinical trials. His work specifically targets antibody-drug conjugates, radiopharmaceuticals, immunoconjugates, and basket trials.
