FDA Approves Opdivo (Nivolumab) for Lung Cancer

The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) to treat people with a type of advanced lung cancer: squamous non-small cell lung cancer that has grown after they received platinum-based chemotherapy. Opdivo is already on the market to treat advanced melanoma skin cancer that can’t be surgically removed and isn’t responding to other drugs.

Opdivo is the first immunotherapy drug to be approved to treat lung cancer. It works by blocking a protein called PD-1 on certain immune cells. This protein helps cancer cells avoid being found and destroyed by the body’s immune system. Blocking the PD-1 protein can help the immune system recognize the cancer cells and attack them.

The new approval is based on a study that was stopped early after showing the drug helped people live longer. The study involved 272 people with advanced squamous cell non-small cell lung cancer. About half received Opdivo and the other half received the chemotherapy drug docetaxel. Those who received Opdivo lived an average of 3.2 months longer than those who received docetaxel.

The safety and effectiveness of Opdivo was supported by a study of 117 people whose advanced lung cancer had gotten worse after treatment. They all received Opdivo as part of the study. Results showed that 15% of the participants saw their tumors shrink or disappear completely. About half the people who responded to the drug had responses lasting for 6 months or longer.

The FDA granted the approval 3 months ahead of schedule under its priority review program.

The most common side effects of Opdivo are fatigue, shortness of breath, pain, decreased appetite, cough, nausea, and constipation. Less common but more serious side effects can occur if the immune system attacks healthy tissues in the body, such as the lungs, colon, liver, kidneys, or hormone-producing glands.

Opdivo is marketed by Bristol-Myers Squibb.

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