European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) 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 the treatment of advanced (unresectable or metastatic) melanoma in adults. "The starting of the EMA's centralized review process marks a significant milestone in our commitment to make Opdivo available for a broader range of appropriate patients with advanced melanoma and lung cancer in Europe," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "Today's announcement also is a step forward in realizing our vision to change survival expectations, transform the standard of cancer care, and the way patients live with cancer across multiple tumor types. We look forward to working with the EMA during its review process." The type II variation submitted to the EMA in non-squamous NSCLC is supported by data from the landmark, global Phase 3 study, CheckMate -057, which evaluated the survival of patients with advanced non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The type II variation application in advanced melanoma is based on data from two studies: CheckMate -067, a pivotal Phase 3 study that evaluated the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in adults with previously-untreated advanced melanoma, and the Phase 2 CheckMate -069, the first randomized trial evaluating the Opdivo+Yervoy regimen in patients with previously-untreated advanced melanoma, as well as supportive data from the Phase 1b CA209004 study in advanced melanoma.