EMA validates two Opdivo indication extension applications

The European Medicines Agency (EMA) has validated two of Bristol-Myers Squibb’s type II variation applications, which seek to extend the current indication for its immuno-oncology agent, Opdivo.

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.

Validation of the applications confirms that the submissions are complete and starts the EMA’s centralised review process.

BMS committed to making Opdivo available for a broader range of patients

“The starting of the EMA’s centralised 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 realising our vision to change survival expectations, transform the standard of cancer care, and the way patients live with cancer across multiple tumour 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 randomised 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.