Posted from: Monday, December 10, 2018 - 11:13 AM - Present

Keytruda Receives New Indication for Lung Cancer

October 30, 2018 – The U.S. FDA has approved a new indication for Keytruda (pembrolizumab), a PD-1 inhibitor manufactured by Merck. It is now indicated for use in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of the patient’s PD-L1 expression status.

PD-L1 is a protein suspected of playing a role in immune system suppression. It is expressed by some cancer cells, and may contribute to their ability to proliferate in the body by allowing them to hide from cancer-killing T-cells. PD-1 inhibitors like Keytruda block the PD-1 protein that allows PD-L1 to bind to cancer cells, preventing the cells from turning on this immune suppression.

In a clinical trial, patients treated with Keytruda and chemotherapy had a 36% reduction in risk of death, no matter their PD-L1 expressions status, compared to patients treated with chemotherapy alone. For NSCLC, the recommended dose of Keytruda is 200mg given via intravenous (IV) infusion every three weeks.

Keytruda is the first anti-PD-L1 agent to receive FDA approval for first-line treatment of NSCLC regardless of the patient’s PD-L1 status. Originally approved in 2014, it is also indicated to treat melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.

Last Updated Monday, January 21, 2019 - 08:17 AM.