September 28, 2017
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced the expanded use of the VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) and metastatic urothelial carcinoma (mUC)2 in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine TECENTRIQ is approved.3 This unique assay evaluates patient PD-L1 status using immune cell and tumour cell staining within the tumour microenvironment, providing clinicians with information that may guide treatment decisions.4, 5 It was previously approved by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients with NSCLC and mUC who are considering treatment with TECENTRIQ.
With nearly 1.7 million deaths worldwide each year, lung cancer remains the leading cause of cancer deaths.6 Metastatic urothelial carcinoma is associated with a poor prognosis and limited treatment options.
Roche will continue to pursue global regulatory approvals for the PD-L1 (SP142) assay in combination with TECENTRIQ for additional cancer indications. PD-L1 testing is not required for the use of TECENTRIQ, but it may provide additional information for physicians and patient dialogue. The PD-L1 (SP142) assay is for use with the Roche BenchMark series of automated staining instruments.
About the VENTANA PD-L1 (SP142) Assay
The VENTANA PD-L1 (SP142) Assay is available on the Roche BenchMark series of automated staining instruments and uses the OptiView DAB IHC Detection Kit with OptiView Amplification. The PD-L1 (SP142) assay performs specific staining of tumour cells and immune cells in formalin-fixed, paraffin-embedded non-small cell lung cancer (NSCLC) and metastatic urothelial carcinoma (mUC) tissues.
Find more information at www.pdl1ihc.com.
About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
For more information on cancer immunotherapy, visit http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htmh
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VENTANA, BENCHMARK and OPTIVIEW are trademarks of Roche. Other product names and trademarks are the property of their respective owners.