The FDA assigned a Prescription Drug User Fee Act goal date of May 28, 2022.
The FDA has accepted the Bristol Myers Squibb’s supplemental biologics license applications for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 28, 2022.
“Last year, over 19,000 people were diagnosed with esophageal cancer in the United States, and 15,000 people died as a result of this very aggressive disease,” Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb, said in a statement. “Additional treatment options are needed to improve upon outcomes achieved with the current standard of care. We are confident that our immunotherapy-based combinations can provide further clinical benefit and address this critical need.”
The filings were based on results from the pivotal phase 3 CheckMate-648 trial, in which both Opdivo-based treatment combinations — Opdivo plus Yervoy and Opdivo plus chemotherapy — demonstrated a statistically significant and clinically meaningful overall survival benefit compared with chemotherapy in patients with unresectable advanced or metastatic ESCC.
In 2018, there were an estimated 49,450 people living with esophageal cancer in the United States, according to the National Cancer Institute. In 2021, the NCI estimates there will be 19,260 new cases of esophageal cancer and an estimated 15,530 deaths.