Bristol Myers Squibb Co. on Monday said the European Medicines Agency has validated a pair of applications seeking expanded approval of its cancer drug Opdivo.
The New York biopharmaceutical company said validation confirms that the filings are complete and begins the agency's centralized review process for the applications.
Bristol Myers is seeking approval of Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.
The company is also seeking approval for Opdivo as an adjuvant treatment for esophageal or gastroesophageal junction cancer in adults with residual pathologic disease after neoadjuvant chemoradiotherapy and resection.
Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.
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