FDA Approves PD-L1 Test To Evaluate Patients With NSCLC Eligible to Receive Atezolizumab


Officials with the FDA have approved Roche’s VENTANA PD-L1 (SP263) Assay as a diagnostic test to evaluate patients with non-small cell lung cancer (NSCLC) who are eligible to receive atezolizumab (Tecentriq, Genentech).

Atezolizumab received FDA approval on October 15, 2021, as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose stage II-IIIA NSCLC tumors have programmed death ligand-1 (PD-L1) expression on ≥1% of tumor cells. The VENTANA PD-L1 (SP263) Assay is designed to identify patients with NSCLC who are eligible to receive atezolizumab monotherapy for this indication.

“Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release. “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.”

Currently, the standard of care for patients with early-stage lung cancer is surgery to remove the tumor, potentially followed by chemotherapy. According to investigators, approximately 50% of patients given this treatment will have their cancer return after surgery.

In the IMpower010 study—initiated in 2015 to determine how patients respond to atezolizumab following surgery and chemotherapy—the VENTANA PD-L1 (SP263) Assay was used to identify patients whose tumors expressed the PD-L1 protein. In 2021, the investigators reported a 34% reduction in the risk of disease recurrence or death in patients receiving atezolizumab whose tumors were shown to express PD-L1 protein.


Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab) [news release]. Roche; October 22, 2021. Accessed October 22, 2021. https://www.roche.com/media/releases/med-cor-2021-10-22.htm

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