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FDA approves Ventana PD-L1 (SP263) assay for non-small cell lung cancer detection.- Roche

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Last updated:23rd Oct 2021
Published:23rd Oct 2021
Roche announced FDA approval of the Ventana PD-L1 (SP263) Assay in non-small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare.

The current standard of care for patients with early stage lung cancer is surgery to remove the tumor, which may be followed by chemotherapy. Unfortunately, about half of these patients will have their cancer return following surgery. Tecentriq received FDA approval on 15 October 2021 as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose Stage II-IIIA NSCLC tumors have PD-L1 expression on at least 1% of tumor cells. The Ventana PD-L1 (SP263) Assay identifies NSCLC patients who may be eligible for Tecentriq (atezolizumab) monotherapy in this indication.

The Ventana PD-L1 (SP263) Assay was used as part of the IMpower010 study sponsored by Genentech/Roche, to identify patients whose tumors expressed the PD-L1 protein. The IMpower010 clinical study began in 2015 with the goal of understanding how patients would respond to treatment with Tecentriq following traditional surgery and chemotherapy. In 2021, Genentech reported a 34% reduction in the risk of disease recurrence or death amongst Tecentriq patients whose tumors were shown to express PD-L1 protein.

Condition: Non Small Cell Lung Cancer
Type: drug

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