Bristol Myers Squibb Marks Milestone with FDA Approval of Subcutaneous Opdivo Qvantig

FDA Approval:
The FDA has approved Opdivo Qvantig, a subcutaneous version of Bristol Myers Squibb's PD-1 checkpoint inhibitor Opdivo, for most previously approved adult solid tumor indications24.

Administration Time:
The subcutaneous form of Opdivo Qvantig can be administered in 3-5 minutes, compared to 30 minutes for the intravenous (IV) version24.

Clinical Trial:
The approval is based on the Phase 3 CheckMate-67T trial, which demonstrated noninferiority to IV Opdivo and showed an overall response rate of 24% for Opdivo Qvantig compared to 18% for IV Opdivo2.

Market Impact:
The subcutaneous version could capture substantial market share by offering faster administration times and flexibility in treatment settings24.

Anniversary:
This approval comes as Bristol Myers Squibb celebrates 10 years since the initial approval of Opdivo in 20155.

Global Access:
Bristol Myers Squibb has also announced a 10-year strategy, ASPIRE, to advance access to innovative treatments in low- and middle-income countries, including making Opdivo available through the Access to Oncology Medicines (ATOM) Coalition1.

Sources:

1. https://news.bms.com/news/philanthropy/2024/Bristol-Myers-Squibb-Announces-10-Year-Strategy-to-Reach-More-Patients-in-Low--and-Middle-Income-Countries/default.aspx

2. https://www.stocktitan.net/news/HALO/halozyme-announces-fda-approval-of-bristol-myers-squibb-s-opdivo-xsmp9enkoo0e.html

4. https://endpts.com/fda-approves-subcutaneous-version-of-bristol-myers-opdivo/

5. https://www.bms.com/about-us/our-company/history-timeline.html