Benzinga | Aug 20, 2021 01:38PM EDT

Bristol Myers Scores FDA Approval For Opdivo In Postsurgery Bladder Cancer

* Bristol Myers Squibb & Co (NYSE:BMY) has snatched another U.S. license for Opdivo (nivolumab), this time in bladder cancer.

* The FDA has granted approval for Opdivo for the treatment of bladder cancer at high risk of recurrence after radical surgical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status.

* The nod marks Opdivo's third indication in the adjuvant setting, following a 2017 approval in melanoma and a recent go-ahead in esophageal or gastroesophageal junction cancer.

* The approval is based on data from the CheckMate-274 trial.

* Opdivo reduced the risk of disease recurrence or death by 30% in patients with muscle-invasive bladder cancer compared with placebo.

* The drug nearly doubled disease-free survival as patients who received it lived a median of 20.8 months without recurrence, compared with 10.8 months for the placebo group.

* The efficacy in PD-L1 expressing tumors saw a risk reduction on the disease-free survival marker was 45% over placebo.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: BMY shares are up 0.90% at $69.13 during the market session on the last check Friday.