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 Opdivomonotherapy 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.”

For more details, go to: http://news.bms.com/press-release/european-medicines-agency-validates-two-parallel-type-ii-variation-applications-extend