FDA approves Roche’s ventana PD-L1 biomarker assay

19 May 2016 (Last Updated May 19th, 2016 18:30)

The US Food and Drug Administration (FDA) has granted approval to Roche Group’s ventana PD-L1 (SP142) assay as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with tecentriq (atezolizumab) to treat metastatic urothelial cancer (mUC).

The US Food and Drug Administration (FDA) has granted approval to Roche Group's ventana PD-L1 (SP142) assay as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with tecentriq (atezolizumab) to treat metastatic urothelial cancer (mUC).

Tecentriq (atezolizumab) is an immunotherapy from Roche.

The ventana PD-L1 (SP142) assay product is expected to be used in vitro diagnostic (IVD).

"This assay, which supports patients with urothelial cancer, a disease with limited treatment options, has the potential to improve the standard of care."

The test intends to evaluate patient PD-L1 status using immune cell staining and scoring within the tumour microenvironment, providing clinicians with information that could help in making immunotherapy decisions.

Roche said that the personalised cancer immunotherapy and complementary diagnostic is the first major advancement in the treatment of urothelial cancer (UC).

UC is the fourth most common cancer diagnosed in men in the US and accounts for 5% of all new cancers reported.

Nearly 77,000 new cases of UC are diagnosed in the US per year, with around 16,000 deaths occurring each year.

Men are three to four times more prone to suffer from this cancer.

Roche Diagnostics North America head Jack Phillips said: "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.

"This assay, which supports patients with urothelial cancer, a disease with limited treatment options, has the potential to improve the standard of care."

The company intends to continue to pursue regulatory approval for the PD-L1 (SP142) assay in combination with tecentriq in other cancer indications and in other countries.

PD-L1 testing is not required for the use of Tecentriq, but it could provide more information for physicians and inform patient dialogue.

The PD-L1 (SP142) assay is currently accessible for use with Roche's benchmark ultra automated staining instrument.