Nivolumab gets expanded approval to treat advanced lung cancer

Nivolumab gets expanded approval to treat advanced lung cancer

12 Oct 2015

The U.S. Food and Drug Administration approved nivolumab (Opdivo) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, nivolumab may help the body’s immune system fight the cancer cells.

Earlier this year, the FDA approved nivolumab to treat patients with advanced squamous NSCLC whose disease progressed during or after platinum-based chemotherapy. This approval expands the use of nivolumab to also treat patients with non-squamous NSCLC.

“While nivolumab 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 «said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Positive patient outcomes leading to the approval

The safety and effectiveness of nivolumab for this use was demonstrated in an international, open-label, randomized study. In the trial participated 582 patients with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy.

Participants were treated with nivolumab or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (the percentage of patients who experienced complete or partial shrinkage of their tumors). After analyzing the results, scientists reported that:

  • Those treated with nivolumab lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel.
  • Additionally, 19% of those treated with nivolumab experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12% among those taking docetaxel, which lasted an average of six months.


PD-L1 test also received approval

While patients who received nivolumab lived longer than those who received docetaxel across the study, 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 nivolumab.

Therefore, 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 nivolumab.

Common side effects of the treatment

The most common side effects of nivolumab are fatigue, musculoskeletal pain, decreased appetite, cough and constipation.

Nivolumab also has the potential to cause serious side effects that result from the immune system effect of nivolumab (known as “immune-mediated side effects”).These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.

The FDA granted nivolumab breakthrough therapy designation for this indication based on preliminary clinical evidence that suggested nivolumab may offer a substantial improvement over available therapies. It also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.


Source: eCancer News

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