FDA Expands Approval for Companion Diagnostic for Keytruda in Non-Small Cell Lung Cancer


The Food and Drug Administration expanded the approval for the first and only companion diagnostic to identify patients with non-small cell lung cancer who would benefit from Keytruda treatment.

The Food and Drug Administration (FDA) expanded the approval of the first and only companion diagnostic to Keytruda (pembrolizumab) in non-small cell lung cancer (NSCLC), the PD-L1 IHC 22C3 pharmDx assay, according to Agilent Technologies, the diagnostic’s manufacturer.

The assay is now approved to identify a broader range of patients with stage 3 or metastatic NSCLC that qualify for first-line treatment with Keytruda, a targeted anti-PD-1 therapy. The diagnostic was previously approved to identify patients with metastatic NSCLC whose tumors express PD-L1 expression levels of 50% or more and would benefit from first-line treatment with Keytruda.

Patients with stage 3 NSCLC who are not candidates for surgical resection or definitive chemoradiation, those with metastatic NSCLC and patients whose tumors show PD-L1 expression of 1% or more are eligible for first-line treatment, per the updated indication. This will allow pathologists to identify a larger population of previously untreated patients who are now appropriate for first-line treatment with Keytruda.

“Anti-PD-1 therapies are a promising treatment class for many cancer types, and PD-L1 testing provides key information to physicians managing stage 3 or metastatic NSCLC patients,” Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said in a press release. Expanding the use of PD-L1 IHC 22C3 pharmDx “broadens the scope of patients that can be identified for first-line treatment with Keytruda and offers new hope to the many patients diagnosed with stage 3 or metastatic NSCLC,” Raha added.

NSCLC accounts for nearly 85% of all lung cancer diagnoses and carries a five-year survival rate of 15%. PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and pathology labs play a crucial role in identifying patients that are eligible for first-line treatments, the release said.

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