Bristol Myers Announces EMA Validates Two Parallel Type II Variation Applications to Extend Opdivo Indication in Europe

Bristol-Myers Squibb Company

today announced that the European Medicines Agency (EMA) has validated two of the company's type II variation applications, which seek to extend the current indication for its Immuno-Oncology agent, Opdivo. Validation of the applications confirms that the submissions are complete and starts the EMA's centralized review process. In lung cancer, the proposed new indication addresses the non-squamous NSCLC population -- Opdivo as monotherapy for the treatment of locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults. In melanoma, the proposed new indication aims to extend the use of Opdivo monotherapy to its use in combination -- Opdivo in combination with Yervoy for