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Roche Complementary Dx, Bladder Cancer Immunotherapy Get FDA Nod

NEW YORK (GenomeWeb) – The US Food and Drug Administration today approved the Ventana PD-L1 (SP142) Assay as a complementary diagnostic for Roche's new metastatic urothelial cancer drug, called Tecentriq (atezolizumab).

The agency simultaneously approved the complementary diagnostic alongside the PD-L1 inhibitor Tecentriq, noting that the immunohistochemistry test "may help identify patients who are more likely to respond to treatment." The test is marketed by Ventana Medical Systems, a Roche subsidiary. This is the first PD-L1 inhibitor approved for bladder cancer.

In a single-arm 310-patient trial, nearly 15 percent of participants saw their tumors shrink, and their responses lasted from 2.1 months to more than 13.8 months. However, in patients deemed to be positive for PD-L1 expression, 26 percent responded compared to 9.5 percent of PD-L1-negative patients.

"Roche's ability to deliver a predictive test for our pathology customers, who provide important clinical information to oncologists, ultimately benefits patients in search of answers and treatment options," Jack Phillips, head of Roche Diagnostics North America, said in a statement. "This assay, which supports patients with urothelial cancer — a disease with limited treatment options — has the potential to improve the standard of care."

Unlike companion diagnostics, which from a regulatory standpoint are required for the safe and effective use of a drug, complementary diagnostics are intended to help but not required to guide treatment strategies, which Roche highlighted in announcing the approval of the test.

The company further said that it will continue to pursue regulatory approval for the PD-L1 (SP142) assay alongside Tecentriq for other indications and in other countries.