FDA, EMA Accept Filings for New Cancer Use for BMS’ Opdivo
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Bristol-Myers Squibb reports that its US and European marketing applications to expand the use of Opdivo (nivolumab) for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were accepted for filing by the US Food and Drug Administration (FDA) and validated by the European Medicines Agency (EMA).

Opdivo is Bristol-Myers Squibb’s immuno-oncology drug poised for blockbuster status with 2019 projected revenues of nearly $8.9 billion according to a recent Thomson Reuters analysis.

In the US, the FDA accepted the company's supplemental biologics license application (sBLA) for Opdivo in SCCHN with priority review, and previously granted the agent breakthrough therapy designation in April 2016. The projected FDA action date is November 11, 2016. In Europe, the EMA validated a Type II variation application for the same patient population. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.

Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway's suppressive signaling on the immune system, including the interference with an anti-tumor immune response. Opdivo was first approved in July 2014, and currently has regulatory approval in 53 countries, including the United States, Japan, and in the European Union.

In the US, the drug is approved for multiple cancer indications. It is indicated as a single agent for treating patients with BRAF V600 wild-type unresectable or metastatic melanoma. It is also approved as a single agent for treating patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with the company’s Yervoy (ipilimumab) for treating patients with unresectable or metastatic melanoma.

It is also approved for treating patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy and with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. It is also indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post- transplantation brentuximab vedotin.

Source: Bristol-Myers Squibb

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