Roche's VENTANA PD-L1 Assay Gets FDA Approval As Companion Diagnostic For Tecentriq In NSCLC

Swiss drug major Roche (RHHBY) announced Friday the U.S. Food and Drug Administration approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer or NSCLC as a companion diagnostic test for Tecentriq (atezolizumab).

The company noted that the VENTANA PD-L1 Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study.

The current standard of care for patients with early stage lung cancer is surgery to remove the tumor, which may be followed by chemotherapy. About half of these patients will have their cancer return following surgery.

Tecentriq received FDA approval on October 15 as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose Stage II-IIIA NSCLC tumors have PD-L1 expression on =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 Roche's unit Genentech to identify patients whose tumors expressed the PD-L1 protein.

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