The U.S. Food and Drug Administration has approved the use of the immunotherapy drug Opdivo for an additional form of advanced lung cancer. The drug had already been approved for use against melanoma and for advanced cases of a different form of lung cancer. Opdivo is made by Bristol-Myers Squibb.
Opdivo was approved for use in patients with non-squamous non-small cell lung cancer when the disease has progressed despite the use of chemotherapy. It was first approved to treat advanced melanoma, the most deadly form of skin cancer, and later for squamous non-small cell lung cancer. The generic name for Opdivo is nicolumab.
While the additional approval was widely expected because clinical trials of Opdivo had gone well, the announcement from the FDA came about 3 months ahead of schedule.
Up to 90% of all cases of lung cancer are non-small cell lung cancer. Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, the FDA said. Squamous cell non-small cell lung cancer accounts about 25% to 30% of non-small cell cases, with non-squamous accounting for between 45% and 60%. Squamous and non-squamous refer to the type of cells in which the cancer occurs, which are generally found in different parts of the lung.
More people have lung cancer than have melanoma, which means that it will be a more lucrative market for drugs like Opdivo that help the immune system fight the disease.
The FDA has already approved an expanded use for Keytruda, a drug from Merck & Co. that is similar to Opdivo. Both Opdivo and Keytruda are designed to block the interaction between two proteins in cancer cells, PD-L1 and PD-1. This interaction stops the immune system from attacking the cancer. By blocking this interaction, these drugs enable the patient's own immune system to attack the cancer.
