Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC.
Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.
First FDA approved in 2014 for advanced melanoma, Opdivo has won a score of oncology indications over the years.
The drug now has five indications covering upper gastroesophageal cancers.
The two recent approvals are based on data from the Phase 3 CheckMate -648 trial, which Bristol Myers Squibb notes is the largest Phase 3 trial of an immunotherapy in first-line ESCC. In that study, Opdivo with chemotherapy offered a superior overall survival rate than chemotherapy alone.
Opdivo with Yervoy also led to improved survivability compared to chemotherapy alone.
“Today brings welcome news for many advanced or metastatic esophageal squamous cell carcinoma patients and oncologists,” said Dr. Jaffer A. Ajani, CheckMate -648 lead U.S. investigator. “Unresectable advanced or metastatic esophageal squamous cell carcinoma is a challenging disease. There’s a need for additional treatment options that may extend survival in the first-line setting,” Ajani added in a news release. “In the CheckMate -648 trial, two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”
In 2021, the drug generated $7.5 billion in international sales, making it the twelfth best-selling drug of the year.
Earlier this month, BMS announced that Opdivo with Yervoy failed to beat chemotherapy at improving overall survival in patients with untreated unresectable or metastatic urothelial carcinoma in the Phase 3 CheckMate -901 study. That study focused on patients with tumors expressing at least 1% of the PD-L1 biomarker.