San Francisco, CA - PD-L1 inhibitor atezolizumab has been approved by the U.S. Food and Drug Administration (FDA) for use with chemotherapy-refractory metastatic Non-Small Cell Lung Cancer (NSCLC) patients.
Atezolizumab, or Tecentriq, was approved earlier this year to treat bladder cancer in those with disease progression during or following platinum-based chemotherapy.
“Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway,” said Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells,” said Dr. Pazdur.
The drug is considered a PD-L1 inhibitor because it’s an antibody that binds to programmed cell death ligand 1 protein (PD-L1) on tumor cells, causing anti-tumor activity. This is an immunotherapy as it uses part of the immune system to treat diseases.
With this type of therapy, antibodies block negative immune regulators, commonly referred to as checkpoints, and the immune system of the human body can react against the cancer cells.
Currently, immunotherapy for mesothelioma is passive and involves targeted immunotherapies that seek out one particular kind of cell or antigen rather than stimulating the entire immune system.
According to lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation Bonnie Addario, “The approval of Tecentriq is another important step for patients by increasing the number of medicines available to people living with lung cancer.”
Similar PD-L1 inhibitors are currently in clinical trials to determine their effectiveness for malignant pleural mesothelioma cancer. This is a Phase II study only given to promising new or experimental therapies in patients to determine the effectiveness of a research treatment after safety has been evaluated in a Phase I trial.
Patients are closely observed for an anticancer effect by careful measurement of cancer sites present at the beginning of the trial. In addition to monitoring patients for response, any side effects are carefully recorded and assessed.
ClinicalTrials.gov is a registry of federally and privately sponsored clinical trials that are currently being conducted in the U.S. and 173 other countries around the world. The site was developed by the U.S. National Institutes of Health (NIH) in collaboration with all NIH Institutes and the FDA following the FDA Modernization Act of 1997.