FDA accepts Bristol Myers Squibb’s sBLA for Opdivo for urothelial carcinoma therapy

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental biologics licence application (sBLA) for Opdivo (nivolumab) plus cisplatin-based chemotherapy as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma for priority review.

90% of bladder cancer cases are attributed to urothelial carcinoma, which typically originates in the cells lining the inner wall of the bladder.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to leverage the body’s immune system to restore anti-tumour immune response.

The sBLA was based on data from the Phase III CheckMate -901 study, in which this combination demonstrated statistically significant and clinically meaningful survival benefits compared to standard-of-care gemcitabine plus cisplatin.

Opdivo plus cisplatin-based chemotherapy, followed by Opdivo monotherapy, showed improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival as evaluated by a blinded independent central review.

Opdivo and Opdivo-based combinations have demonstrated improvements in OS in Phase III studies of advanced renal cell carcinoma, non-small cell lung cancer, metastatic urothelial carcinoma, metastatic melanoma, malignant pleural mesothelioma and oesophageal squamous cell carcinoma.

In August 2023, the European Commission approved Opdivo as an adjuvant treatment for stage IIB or IIC melanoma patients who have undergone complete resection. The approval was based on positive data from the double-blind, randomised Phase III CheckMate -76K trial.