Nivolumab Approved for Advanced Lung Cancer

Opdivo, whose chemical name is nivolumab, is approved to treat advanced melanoma and a type of non-small cell lung cancer.

Bristol-Myers Squibb Co.’s (BMY) cancer drug Opdivo, also known chemically as nivolumab, has received FDA approval for yet another indication – this time, for the treatment of patients with metastatic non-squamous non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Squamous and non-squamous refers to the type of cells in which the cancer occurs, and they tend to be situated in different parts of the lung. Therefore, molecular characterization (“testing”) of the patient’s tumor is crucial for the right choice of therapy.

Opdivo woks by targeting proteins (PD-1/PD-L1) that are found in a few cancer cells, potentially boosting the immune system’s ability to fight the cancer.

“The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated”, explains Dr. Edward Garon, who is a researcher at the University of California Los Angeles, in a recent interview.

The safety and effectiveness of Opdivo for this use was demonstrated in an global, 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. Patients who received nivolumab achieved longer OS – the study’s primary endpoint – than patients assigned docetaxel (12.2 months vs. 9.4 months). Additionally, 19% of the group given Opdivo reportedly saw their tumors shrink, an effect that lasted an average of 17-months, compared to 12% among those taking docetaxel, which lasted an average of 6-months.

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