FDA Grants Breakthrough Therapy Status for BMS’ Cancer Drug
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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bristol-Myers Squibb’s Opdivo (nivolumab) for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.

The breakthrough therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.

This is the fifth breakthrough therapy designation granted for Opdivo by the FDA, with previous indications including patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and advanced or metastatic renal cell carcinoma.

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. It currently has regulatory approvals in 50 countries, including the United States, Japan, and in the European Union. In the US, it is approved for the following: (1) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma; (2) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma; (3) foor the treatment of patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy; and for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

Source: Bristol-Myers Squibb

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