Last week, the U.S. Food and Drug Administration made a major announcement. This is kind of technical, but bear with me – it’s worth it.
Merck & Co.’s immunotherapy drug Keytruda® has been approved for use in previously untreated lung cancer patients.
Key point: the phrase “previously untreated.” This is the first time that an immunotherapy drug has been approved as the first-line treatment for lung cancer, providing an option other than chemotherapy.
I have blogged previously about immunotherapy drugs. These treatments use the body’s own immune system to fight disease. Keytruda has been approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. PD-L1 is a protein that can suppress the body’s immune system. Keytruda works by blocking PD-L1, enabling the immune system to better do its job.
Key point: Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC accounts for 80 percent of all lung cancers.
Agilent has partnered with several pharmaceutical companies – including Merck – to develop companion diagnostics tests. These tests help determine whether a specific patient should be considered for a particular treatment.
Key point: Imagine that a cancer treatment was only effective for 15 percent of patients. But then, imagine if you could identify beforehand who those 15 percent would be. Pretty powerful stuff!
Agilent’s Dako PD-L1 IHC 22C3 pharmDx is a companion diagnostic that detects the expression of PD-L1 in NSCLC patients. This helps identify potential candidates for treatment with Keytruda.
With the Merck announcement, Agilent has also received expanded FDA approval for pharmDx. This expanded intended use now allows Agilent’s companion diagnostic test to detect PD-L1 expression in a broader range of patients – specifically, those with a PD-L1 tumor proportion score of 1 percent or more.
Key point: This marks the first time an Agilent PD-L1 companion diagnostics assay has been approved for first-line testing for lung cancer.
The updated approval means that Agilent’s assay can be used to identify previously untreated patients with metastatic NSCLC expressing high levels of PD-L1 for treatment with Keytruda. The labeling update also means that more patients in the second-line or later treatment setting can also be identified for treatment with Keytruda.
Key point: Take that, cancer!
For more information go to:
- Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor (U.S. FDA)
- FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Metastatic NSCLC for First-Line Treatment of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) With No EGFR or ALK Genomic Tumor Aberrations (merck.com)
- Agilent is Partnering with Pharma to Help Your Immune System Fight Cancer
- Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small Cell Lung Cancer (NSCLC)
- Dako: Agilent Pathology Solutions