The United States Food and Drug Administration (FDA) has expanded the approval of Opdivo® (nivolumab) for the treatment of non-squamous, non-small cell lung cancer.

Non-small cell lung cancer (NSCLC), the most common type of lung cancer, is divided into two main groups based upon the type of cells comprising the cancer: non-squamous and squamous cell.

Nivolumab is already approved for the treatment of squamous cell NSCLC, while the expanded approval includes treatment of non-squamous NSCLC. Nivolumab is to be used for the treatment of advanced NSCLC that has progressed following, or during, treatment with a platinum-based chemotherapy.

Nivolumab is known as a PD-1 inhibitor because it inhibits the PD-1/PD-L1 pathway in cells. Through inhibiting this pathway, the immune system is able to help fight cancer.

The clinical trial that prompted the expanded approval of nivolumab included 582 patients with advanced NSCLC whose cancer continued to grow following prior therapy that included a plastinum-based chemotherapy agent.

Patients in the trial were treated with either nivolumab or the chemotherapy agent docetaxel. Patients treated with nivolumab had an average survival of 12.2 months, compared with 9.4 months for those treated with docetaxel and19% of patients treated with nivolumab experienced a regression of their cancer, lasting an average of 17 months, compared with 12% of patients treated with docetaxel experiencing a regression of their cancer, lasting an average of 6 months.

A subgroup analysis identified that patients with a higher PD-L1 expression in their cancers had a significantly greater response to nivolumab compared to those with a lower PD-L1 expression.

In the press release published by the FDA announcing the expanded approval of nivolumab, it was stated that “an evaluation of samples from a subgroup of patients’ tumors suggests that the level of PD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer due to treatment with Opdivo. Therefore, today the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and help physicians determine which patients may benefit most from treatment with Opdivo.”

Reference: United States Food and Drug Administration (FDA). FDA News Release. FDA expands approved use of Opdivo in advanced lung cancer. Available at: Accessed October 11, 2015.



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