FDA greenlights Opdivo for frontline metastatic bladder cancer

2024-03-07

临床结果临床3期优先审批上市批准

Bristol Myers Squibb's PD-1 checkpoint blocker Opdivo (nivolumab) was approved by the FDA on Thursday for first-line patients with the most common type of bladder cancer.

The new indication is for Opdivo in a combo regimen with cisplatin and gemcitabine to treat patients with unresectable or metastatic urothelial carcinoma (UC).

"This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches," said Guru Sonpavde, an investigator on the Phase III CheckMate-901 trial used to support the regulatory filing, which had been granted a priority review.

The 608 cisplatin-eligible patients in the study were randomised to receive Opdivo plus cisplatin and gemcitabine followed by Opdivo monotherapy, or cisplatin-gemcitabine alone.

Both survival endpoints were met. The Opdivo combo reduced the risk of death by 22%, demonstrating a median overall survival of 21.7 months, compared to 18.9 months with cisplatin-gemcitabine alone. The regimen also showed a 28% benefit on progression-free survival (PFS), which was 7.9 months with Opdivo versus 7.6 months for controls.

Key opinion leaders (KOLs) interviewed for a FirstWord report last year couldn't come to a consensus regarding the drug's uptake. It has been approved in the US as a bladder cancer treatment since 2017 for previously treated patients with locally advanced or metastatic disease. Its label was later expanded to include adjuvant treatment for those at high risk of recurrence after radical resection.

The KOLs suggested that in the next to three-to-five years, Opdivo's use will depend on how it fares in potential combinations. For more, see Spotlight On: Checkpoint inhibitors jockey for relevance in bladder cancer.

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