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October 22, 2021updated 28 Jul 2022 9:51am

FDA approves Roche Ventana PD-L1 as companion test for lung cancer

The Ventana PD-L1 test helps identify NSCLC patients who may be eligible for treatment with Tecentriq monotherapy.

The US Food and Drug Administration (FDA) has approved the Roche VENTANA PD-L1 (SP263) Assay as an accompanying diagnostic test for identifying patients with non-small cell lung cancer (NSCLC) eligible for treatment with Tecentriq (atezolizumab).

Currently, surgery to remove tumours is the standard treatment for early-stage lung cancer patients, which can be followed by chemotherapy.

However, the cancer is found to return following an operation in about half of patients.

Recently, the Roche therapy Tecentriq has been approved by the FDA as an adjuvant treatment after operation and platinum-based chemotherapy for adult patients whose NSCLC tumours are in stage II-IIIA and have PD-L1 expression on ≥1% of cells.

The new Ventana PD-L1 test detects programmed death ligand-1 (PD-L1) protein in NSCLC patients and helps in identifying individuals eligible for treatment with Tecentriq monotherapy in this indication.

Roche Diagnostics CEO Thomas Schinecker said: “Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options.

“We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for Tecentriq therapy.

“With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment.”

The company stated that the new assay was used as part of the Phase III, open-label, multicentre randomised controlled IMpower010 study, which was backed by Roche’s subsidiary, Genentech.

It was used for identifying patients whose tumours expressed the PD-L1 protein.

As reported by Genentech, the risk of disease recurrence or death among patients treated with Tecentriq was reduced by 34%.

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