Bristol-Myers Squibb’s Cancer Drug Opdivo Receives another Approval from FDA

Bristol-Myers Squibb Co. receives another approval from the Food and Drug Administration (FDA) for its cancer drug Opdivo, also known chemically as nivolumab. This time the approval is for the treatment of patients with metastatic non-squamous non-small cell lung cancer.

According to the National Cancer Institute lung cancer is the number one cause of cancer death in the US. An estimated 221,200 new cases were diagnosed and more than 158,000 deaths were recorded last year.

The expanded approval was based on results from a phase III trial, dubbed CheckMate-057. Researchers during the trial noted that Opdivo demonstrated superior overall survival in previously treated metastatic non-squamous NSCLC patients as compared to standard chemotherapy drug Docetaxel.

It was noted that Opdivo reduced the risk of death by 27%. The median overall survival was 12.2 months in the Opdivo arm and 9.4 months in the Docetaxel arm.

The approval for the drug by FDA has come nearly three months ahead of the FDA's scheduled decision date of January 2, 2016.

As per its makers, Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body's immune system from attacking cancerous cells.

Opdivo was previously approved for the treatment of advanced melanoma by the FDA in last December. It received a second FDA approval on March 4, 2015, for the treatment of patients with advanced squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

Opdivo in total sales made $162 million for the six months ended June 30, 2015. Bristol-Myers Squibb closed Friday's trading at $61.44, up 1.54%.

“There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” stated Dr. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s 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.”