US FDA approves breakthrough drug as first-line treatment for lung cancer

An immunotherapy drug called pembrolizumab, which was extensively evaluated by University of California, Los Angeles (UCLA) cancer researcher Dr. Edward Garon, has been approved by the US Food & Drug Administration (FDA) as first-line treatment for non-small cell lung cancer (NSCLC).

As a first-line treatment, it means that the drug may be accessed by some patients without having to receive other treatments first, such as chemotherapy.

The FDA also expanded the approval of pembrolizumab to treat the majority of people with NSCLC who had received prior chemotherapy, greatly increasing the patient population that can benefit from the treatment.

Expressing his excitement regarding the expanded group of patients who can access the drug, Garon, whose clinical studies helped lead to today’s FDA approval, said: “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. This will allow them to live longer while delaying, and in some cases potentially avoiding, the side effects of traditional chemotherapy.”

Pembrolizumab, marketed under the brand name Keytruda, works by turning off the immune system’s brakes, allowing its T-cells to recognize and attack cancer cells. It originally received accelerated approval by the FDA in 2015 as a treatment for NSCLC.

Until today’s approval, however, the drug was only given to patients after prior chemotherapy who expressed a biomarker known as PD-L1 on at least half of their cancer cells. Now, patients with PD-L1 expression on at least half of their cancer cells can receive pembrolizumab prior to standard chemotherapy.

The idea to specifically study this group of patients was based on groundbreaking research Garon published last year, which found that among patients who received pembrolizumab, those with PD-L1 expression on at least 50% of their cancer cells showed the longest survival and disease control. Garon’s work laid the foundation for additional research that led the way for today’s approval.

Issued concurrently by the FDA today is a new label update for pembrolizumab, which can now be prescribed to patients who express PD-L1 on as few as 1% of their cancer cells if they have received prior chemotherapy. This recommendation is based on a separate study, in which Garon was the senior author, showing longer survival than chemotherapy among patients with any positive staining for PD-L1.

Researchers are currently testing pembrolizumab to determine if it has the same result in other cancers, as well as trying to combine pembrolizumab with other therapies.

Lung cancer is the deadliest cancer worldwide and The American Lung Association estimates more than 158,000 people in the US will die from the disease this year alone. NSCLC accounts for approximately 85% of all lung cancers.

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Category: Features, Pharmaceuticals