NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved the PD-L1 (SP142) Assay developed by Roche subsidiary Ventana as a complementary diagnostic for Genentech's PD-L1 inhibitor Tecentriq, which was recently approved to treat lung cancer.
The complementary assay, while not required for the safe and effective use of Tecentriq, can determine patients' PD-L1 expression levels, which in turn "can provide insight into the survival benefit that may be achieved" with treatment, Roche said in a statement today. The test gauges PD-L1 expression in tumor and immune cells.
Last week, the FDA expanded the indication for Tecentriq (atezolizumab) as a treatment for metastatic non-small cell lung cancer patients who have progressed despite treatment with platinum-based chemotherapy. "Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” Sandra Horning, Genentech's chief medical officer, said in a statement.
The approval was based on two randomized studies involving more than 1,100 NSCLC patients, in which those receiving Tecentriq lived longer by 4.2 months and 2.9 months compared to patients receiving docetaxel. Patients on Tecentriq experienced common adverse reactions, such as fatigue, decreased appetite, and dyspnea. Grade 3 and 4 toxicities included dyspnea, pneumonia, and hypoxia, and some patients experienced immune-related events, such as pneumonitis, hepatitis, colitis, and thyroid disease.
Earlier this year, the agency granted accelerated approval for Tecentriq as a treatment for metastatic urothelial cancer patients who have progressed after platinum-containing chemotherapy. The agency approved that indication alongside the PD-L1 (SP142) complementary test as a tool that can identify patients who can benefit from treatment.