First-line Designation Granted to Immunotherapy in Advanced Lung Cancer

The FDA has approved the immunotherapy pembrolizumab (Keytruda) as a first-line treatment in patients with non-small cell lung cancer (NSCLC).

Keytruda, which underwent extensive evaluation, has also been expanded to treat the majority of NSCLC patients who received prior chemotherapy.

“It is exciting to have an expanded group of patients who ae not eligible for this drug,” said senior study author

“What is particularly encouraging is that we are now able to select, based on features in the tumor, approximately a quarter of advanced lung cancer patients who can receive immunotherapy as their initial treatment,” said Edward Garon, UCLA cancer researcher who evaluated pembrolizumab. “This will allow them to live longer while delaying, and in some cases potentially avoiding, the side effects of traditional chemotherapy.”

Keytruda is designed to shut off the immune system’s brakes to allow its T cells to recognize the cancer cells and send out an attack.

In 2015, Keytruda was granted accelerated approval as a treatment for NSCLC. However, only patients who expressed the biomarker PD-L1 on at least half of their cancer cells, and who already had prior chemotherapy, could use the drug.

Additionally, the FDA has also issued a new label update for Keytruda, which will allow the drug to be prescribed to patients who express PD-L1 on as few as 1% of their cancer cells if they received prior chemotherapy.

Currently, Keytruda is being tested to see if it has the same result on other types of cancer, and to determine its efficacy in combination with other therapies.