Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma
- Urothelial carcinoma, the most common type of bladder cancer, is the fourth most common cancer in men in the United States 1
- PD-L1 is a protein involved in the suppression of the immune system, which can impact the body’s ability to fight cancer
- Use of the VENTANA PD-L1 (SP263) Assay2 to determine PD-L1 expression in urothelial carcinoma may help to inform the likelihood of responding to IMFINZI™ (durvalumab) immunotherapy
Tucson, AZ, May 2, 2017 Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic3 to provide PD-L1 status for patients with locally advanced or metastatic urothelial carcinoma (mUC)4 who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy IMFINZI™ (durvalumab, AstraZeneca). The test evaluates patient PD-L1 status using both tumor and immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide treatment decisions. PD-L1 is a protein involved in the suppression of the immune system, which can impact the body’s ability to fight cancer. Understanding the expression of PD-L1 in tumors can help identify patients most likely to benefit from immunotherapy.
It is estimated that in 2017, approximately 79,000 Americans will be diagnosed with bladder cancer and almost 17,000 will die from this disease. Men are three to four times more likely than women to suffer from this cancer.1
“Urothelial carcinoma is an area of significant unmet medical need,” said Ann Costello, Head of Roche Tissue Diagnostics. “We are very pleased the VENTANA PD-L1 (SP263) Assay has received FDA approval as it will serve as a powerful tool to help inform physicians about appropriate treatment options for their patients.”
Roche continues to pursue regulatory approval for the VENTANA PD-L1 (SP263) Assay in other cancer indications in the US and in other geographies. This collaboration with AstraZeneca demonstrates Roche’s continued commitment to personalized medicine through innovative diagnostic solutions.
1American Cancer Society, 2017 bladder cancer statistics.
2This product is intended for in vitro diagnostic (IVD) use.
3Complementary diagnostic is a test that aids in the benefit-risk decision making about use of the therapeutic product. (Reena Phillips. Developing Diagnostics: Perspective From the FDA. ASCO 2016 presentation, http://meetinglibrary.asco.org/content/51097?media=vm )
4Metastatic urothelial carcinoma (mUC) is also known as transitional cell carcinoma (TCC) of the urinary tract or urothelial bladder cancer. The majority of urothelial tumors arise in the bladder with the remainder originating in the renal pelvis, urethra or ureter.
About VENTANA PD-L1 (SP263) Assay
VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the Programmed Death Ligand (PD-L1) in a growing number of cancer indications. The assay is available in the US for use on the BenchMark ULTRA instrument.
The use of the VENTANA PD-L1 (SP263) Assay for PD-L1 expression testing in either tumor or immune cell membranes in urothelial carcinoma may be a useful tool to help determine the likelihood of responding to IMFINZI™ (durvalumab) but is not required for use of IMFINZI.
Find more information and available testing locations at www.pdl1ihc.com.
IMFINZI™(durvalumab) is a human monoclonal antibody directed against PD-L1. Durvalumab is also being studied in the first-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which enrolled its first patient during the fourth quarter of 2015. Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in non-small cell lung cancer, head and neck squamous cell carcinoma, bladder, hepatocellular carcinoma and blood cancers. IMFINZI is a trademark of the AstraZeneca group of companies and is manufactured and distributed by AstraZeneca.
For more information on IMFINZITM (durvalumab), visit www.imfinzi.com
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VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.
VENTANA PD-L1 (SP263) Assay staining in urothelial carcinoma (UC)