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Bristol-Myers Squibb Says New Opdivo Formulation Recommended for Approval by EU Regulatory Panel
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Bristol-Myers Squibb Says New Opdivo Formulation Recommended for Approval by EU Regulatory Panel
Mar 28, 2025 6:39 AM

09:14 AM EDT, 03/28/2025 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval for a new formulation of Opdivo with a new route of administration.

The company said the new formulation, which includes recombinant human hyaluronidase, is indicated for multiple adult solid tumors as a monotherapy, maintenance therapy following nivolumab plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.

The drugmaker said the recommendation is based on trial results showing that subcutaneous and intravenous Opdivo have similar pharmacokinetics and safety profiles.

The European Commission will review the opinion, with a final decision expected within two months, the company said.

Additionally, Bristol Myers Squibb ( BMY ) said the European health agency also recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer in certain adults.

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