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FDA Gives Green Light to Subcutaneous Opdivo – What This Means for Cancer Patients

Daniel Kim Views  

FDA approves subcutaneous version of Bristol Myers Squibb\'s cancer drug \'Opdivo.\' (Photo=DB)
FDA approves subcutaneous version of Bristol Myers Squibb’s cancer drug ‘Opdivo.’ (Photo=DB)

The U.S. Food and Drug Administration (FDA) has announced that a subcutaneous version of Bristol Myers Squibb’s (BMY.N) blockbuster cancer treatment, Opdivo, significantly advances cancer therapy administration.

Opdivo, a PD-1 inhibitor that boosts the immune system’s cancer-fighting capabilities, was previously only available as an intravenous infusion.

The FDA recently reported that the new subcutaneous formulation demonstrated comparable efficacy to its intravenous counterpart in patients with advanced kidney cancer who had undergone prior systemic treatment.

The newly approved subcutaneous version, Opdivo Qubtanic, is now authorized for all adult solid tumor indications previously approved for intravenous Opdivo. It can be used either as a standalone maintenance therapy or in combination with chemotherapy. In particular, Opdivo Qbantic is more convenient for patients and is expected to help compensate Bristol for its revenue loss due to the expiration of the intravenous Opdivo patent in 2030.

Bristol Myers Squibb has announced that the injectable Opdivo will be available in early January next year. The company plans to price it at the same level as the intravenous version.

Currently, the intravenous Opdivo is priced at $7,635 for a low-dose two-week treatment and $15,269 for a high-dose (480 milligrams) four-week treatment.

Daniel Kim
content@viewusglobal.com

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