FDA Approves Diagnostic Assay, Identifies Patients Eligible for Lung Cancer Drug Cemiplimab


Ventana PD-L1 (SP263) Assay can increase access to cemiplimab and improve patient outcomes in non-small cell lung cancer.

The FDA has approved the Ventana PD-L1 (SP263) Assay, a companion diagnostic that can identify patients with non-small cell lung cancer (NSCLC) who are eligible for cemiplimab (Libtayo; Regeneron), a PD-1 inhibitor therapy, according to a press release.1

"Diagnostics, like our high medical value PD-L1 assay portfolio, enable personalized medicine to help improve patient outcomes," said Jill German, head of Pathology Lab, Roche Diagnostics, in the press release.1

Lung cancer is the primary cause of cancer-related deaths across the globe. Worldwide, more than 2.2 million people are diagnosed each year, with 85% of cases considered NSCLC. Among NSCLC diagnoses, more than 60% are stage 3 and stage 4 (locally advanced or metastatic stage).1 It is also estimated that 30% of cases are positive for programmed death ligand-1 (PD-L1) in more than 50% of tumor cells.2

Ventana PD-L1 (SP263) Assay detects the PD-L1 protein in patients with NSCLC. Previous clinical studies suggest that determining PD-L1 expression can predict how well a patient will benefit from PD-L1/PD-1 immunotherapy drugs.1

In 2021, the FDA approved cemiplimab as a first-line treatment for patients with NSCLC. Cemiplimab is a fully human monoclonal antibody that binds to PD-1 and stops it from suppressing T-cell activation.The approval was based on results from the EMPOWER-Lung 1 trial.2

The open-label, randomized, multi-center phase 3 trial evaluated cemiplimab monotherapy against platinum-based chemotherapy for patients with advanced NSCLC, positive PD-L1 expression—in 50% or more tumor cells—and no estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 gene aberrations.2

Cemiplimab reduced the risk of death by 43% compared to platinum-based chemotherapy, but it was even efficacious for patients who crossed over from chemoterhapy.2

"Notably, [cemiplimab] was approved based on a pivotal trial where most chemotherapy patients crossed over to [cemiplimab] following disease progression,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of Thoracic Oncology and co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, in a press release. “[T]hat allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation.”

The current product is the only assay FDA-approved for 4 different immunotherapy drugs for NSCLC.1 The approved assay could improve treatment outcomes because it grants patients access to various immunotherapy options and may lead to earlier treatment.1

"This approval helps physicians make more confident treatment decisions by identifying patients with tumors that may respond to the immunotherapy (cemiplimab)," German said in the press release.1


  1. Roche. Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo. News Release. March 6, 2023. Accessed March 8, 2023. https://www.prnewswire.com/news-releases/roche-receives-fda-approval-of-label-expansion-for-ventana-pd-l1-sp263-assay-to-identify-patients-with-locally-advanced-and-metastatic-non-small-cell-lung-cancer-eligible-for-libtayo-301762423.html
  2. Regeneron. FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) MONOTHERAPY FOR PATIENTS WITH FIRST-LINE ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%. News Release. February 22, 2021. Accessed March 8, 2023. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-monotherapy-patients-first
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