Empaveli Approved to Treat Rare Blood Disorder
May 14, 2021Kedrab Approval Expanded to Prevent Rabies in Children
May 20, 2021Opdivo Receives New Indication for Esophageal and Gastroesophageal Junction Cancer
May 20, 2021 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab), manufactured by Bristol Myers Squibb, to provide adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in individuals who have received neoadjuvant chemoradiotherapy (CRT).
Esophageal cancer and GEJ affect sections of the digestive system and can require multiple treatment approaches, including chemotherapy, radiation, and surgery. Patients who have residual pathologic disease following neoadjuvant CRT and complete resection are at high risk of recurrence but have few options for treatment.
In a clinical study, Opdivo delivered a median disease-free survival time of 22.4 months versus 11 months with placebo. Recommended dosing is a 30-minute intravenous infusion of Opdivo 240mg once every two weeks or 480mg once every four weeks, with a total treatment duration of one year.
Opdivo first received FDA approval in 2014 and has more than a dozen indications to treat various types of cancer.