FDA Expands Opdivo for Lung Cancer Treatment

Opdivo was previously approved for patients with squamous NSCLC whose disease progressed during or after platinum-based chemotherapy.

Opdivo was previously approved for patients with squamous NSCLC whose disease progressed during or after platinum-based chemotherapy.

The FDA announced today the expanded approval of nivolumab (Opdivo) to treat patients with advanced non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.

Opdivo targets the cellular pathways known as PD-1/PD-L1, which are proteins found on the body’s immune cells and some cancer cells. In blocking this pathway, Opdivo helps the body’s immune system fight against the cancer cells.

The FDA approved Opdivo earlier this year for patients with squamous NSCLC whose disease progressed during or after platinum-based chemotherapy. The expanded approval also treats patients with non-squamous NSCLC.

“There is still a lot to learn about the PD-1/PD-L1 pathways and its effects in lung cancer, as well as other tumor types,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”

The safety and efficacy of Opdivo was observed in an international, open-label, randomized study of 582 participants with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy. Those involved in the study were either treated with Opdivo or docetaxel.

The goal of the study was to improve overall survival, as well as to achieve a response rate, or percentage of patients who experienced complete or partial shrinkage of their tumors. Results showed that Opdivo allowed patients to live an average of 12.2 months, compared with 9.4 months in those treated with docetaxel.

In addition, 19% of those treated with Opdivo experienced complete or partial shrinkage of their tumors, which lasted an average of 17 months, compared with 12% among those treated with docetaxel, with the effects only lasting an average of 6 months.

While patients who received Opdivo lived longer than those who received docetaxel across the study, an evaluation of samples from a subgroup of tumors suggests that the level of PD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer from treatment with Opdivo.

As a result, the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and to help physicians determine which patients may benefit most from treatment with the drug.

Side effects of Opdivo include fatigue, musculoskeletal pain, decreased appetite, cough and constipation. Opdivo also has the potential to cause more serious side effects, such as immune-mediated side effects that involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands, and the brain.

The FDA granted Opdivo breakthrough therapy status for this indication based on preliminary clinical evidence that suggested Opdivo may offer a substantial improvement over current therapies.