New Treatment Approved for Esophageal and GEJ Cancer in EU

According to a story from Pharma Times, the drug company Bristol Myers Squibb has recently announced that its therapy nivolumab (marketed as Opdivo) has been approved by the European Commission (EC) as an adjuvant therapy for esophageal and gastroesophageal junction (GEJ) cancer. More specifically, it is to be used in adult patients that have been previously treated with neoadjuvant chemoradiation therapy and still show signs of residual pathologic disease.

About Gastroesophageal Junction (GEJ) Cancer

Gastroesophageal junction (GEJ) cancer is an adenocarcinoma that usually affects the lower third of the esophagus. Among esophageal cancers, this form is the more prevalent type in the developed world. Risk factors include being male, acid reflux, obesity, and tobacco use. This can be a dangerous type of cancer because symptoms may not appear until the disease has reached an advanced stage, when it is less likely to be responsive to treatment. Symptoms include difficulty swallowing, pain while swallowing, pain in the chest or stomach the resembles heartburn, a hoarse cough, food regurgitation, vomiting (which can include blood), and nausea. Other symptoms may occur if cancer has metastasized to other parts of the body. Treatments for GEJ cancer may include surgery, chemo, and radiation therapy. Unfortunately, outcomes for GEJ cancer are poor; in the US, the five-year survival rate is only 15 percent for esophageal cancer as a whole. Click here to learn more about GEJ cancer.

Promising Findings

This approval is the result of findings from a phase III clinical trial. In this study, treatment with Opdivo was able to double disease-free survival in patients that have been treated with surgical resection and neoadjuvant chemoradiation previously. This was the primary endpoint of the trial. These results suggest that the drug can prevent recurrence for at least some patients. 

The approval of Opdivo from the EC covers all 27 EU member states as well as Liechtenstein, Norway, and Iceland. The therapy had previously been approved in May of this year for the same indication by the US Food and Drug Administration (FDA). Overall, this therapy could help address a critical unmet need in some GEJ cancer patients.

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