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EMA Accepts Application for Subcutaneous Opdivo Across Multiple Indications

NEW YORK – The European Medicines Agency on Friday validated Bristol Myers Squibb's extension application seeking approval for subcutaneous administration of its PD-1 immune checkpoint inhibitor Opdivo (nivolumab) across multiple previously approved indications.

Based on results from the Phase III CheckMate-67T study, BMS is seeking approval for subcutaneous injection use of Opdivo in certain solid tumor indications as a monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or Exelixis' Cabometyx (cabozantinib). BMS did not disclose the specific solid tumor indications included in the EMA application.

The CheckMate-67T study included patients with previously treated advanced or metastatic clear cell renal cell carcinoma. The subcutaneous Opdivo demonstrated noninferiority versus intravenous Opdivo in endpoints measuring serum concentrations of the drug and objective response rate.

"Subcutaneous nivolumab has the potential to change the way patients living with cancer receive Opdivo treatment and to significantly reduce administration time by utilizing a single injection in three-to-five minutes," Susan Parker, VP and global program lead of product design and development at BMS, said in a statement. "By providing patients the same quality of care as IV Opdivo in a fraction of the time, patients can focus on what is important to them rather than spending a longer wait time at the infusion center."

The EMA's validation of the application confirms the submission is complete and begins the centralized review procedure.

In May, BMS also submitted an application to the US Food and Drug Administration seeking approval for subcutaneous Opdivo across all previously approved solid tumor indications based on the CheckMate-67T results. The FDA is expected to make an approval decision by Feb. 28, 2025.