The U.S. Food and Drug Administration (FDA) announced the approval of PD-L1 IHC 22C3 pharmDx, a lab test, for identifying patients with triple-negative breast cancer (TNBC) who may be suitable for treatment with Keytruda (pembrolizumab).
Agilent Technologies, the developed of the diagnostic test, received the FDA approval.
PD-L1 IHC 22C3 pharmDx is a companion diagnostic approved by the FDA to assist in the identification of patients with TNBC who may benefit from the treatment with Keytruda along with chemotherapy.
Keytruda is a humanized antibody used in cancer immunotherapy. It treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer. The drug is given by slow injection intravenously.
Keytruda with chemotherapy has been approved for patients with recurrent, unresectable, or metastatic TNBC whose tumors have PD-L1 expression.
PD-L1 expression is one of the crucial biomarkers for response to anti-PD-1 therapies like Keytruda. The use of the PD-L1 IHC 22C3 pharmDx test will now help pathologists to identify patients with TNBC who are eligible for treatment with Keytruda.
Nina Green, VP and General Manager at Agilent, said in a press release, “Anti-PD-1 therapies, including [Keytruda], continue to offer new treatment options for a growing population of cancer patients.”
“With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in TNBC, physicians will be able to access critical information to qualify even more patients who could benefit from these treatments,” she added. “This new approval reinforces Agilent’s role as a worldwide leader in developing companion diagnostics for targeted therapies.”
TNBC is the seventh type of cancer for which PD-L1 IHC 22C3 pharmDx has received FDA approval. The test also helps doctors to identify patients with other cancers, such as non-small cell lung cancer, gastric/gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma.