Bristol-Myers
Squibb Company BMY 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
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