Through its accelerated approval program, the US Food and Drug Administration (FDA) has approved a Merck drug now used for treating melanoma for treatment of the most common type of lung cancer.
In its press release on Friday, Oct 2, the FDA has announced that it has approved Keytruda (pembrolizumab), an immune therapy drug, to manage and treat advanced non-small cell lung cancer (NSCLC). This means the patient does not respond to other forms of treatment or the disease has already progressed. It is also recommended for patients whose tumors have the PD-L1 expression.
PD-L1 is a kind of protein that is present in certain cancer cells. The drug works by blocking its pathway and allowing the immune system to have a much better fighting chance against the cancer.
To test the effectiveness of Keytruda, researchers worked with 61 patients who had advanced NSCLC, who received other forms of treatment like platinum-based chemotherapy but didn't respond, and whose tumors were positive of PD-L1. Upon analyses of the results, more than 40% of the tumors shrank while the effect lasted for at least 2.1 months.
As for safety, the drug was tested in 550 advanced NSCLC patients. Most of the patients developed cough and problems of breathing. Others showed immune-mediated side effects including vasculitis and rash.
The drug should be prescribed alongside PD-L1 IHC 22C3 pharmDx test, a diagnostic examination developed by Dako, as it can detect the presence of the protein.
Prior to the approval of Keytruda, the FDA has already granted approval to Opdivo (nivolumab) of Birstol-Meyers Squibb. Although this drug also targets the protein pathway, it is intended for a more specific type of NSCLC called squamous cell NSCLC.
According to American Cancer Society, lung cancer is the one of the deadliest types of cancer in the United States. There are three types of lung cancer, namely, lung carcinoid tumor, non-small cell lung cancer, and small cell lung cancer. More than 80% of the diagnosed lung cancers are NSCLC.