The Phase 3 ATTRACTION-3 clinical trial, which evaluated Opdivo compared to chemotherapy, has supported the Japanese regulatory approval
Entrance to the Bristol-Myers Squibb facility at Wirral, England. (Credit: Rept0n1x/Wikipedia.)
US-based pharmaceutical company Bristol-Myers Squibb has secured Japan’s Ministry of Health, Labor and Welfare (MHLW) approval for Opdivo (nivolumab) to treat unresectable advanced or recurrent esophageal cancer, progressed after chemotherapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to help the body’s own immune system to restore anti-tumour immune response and fight against cancer.
The drug was previously approved by the FDA for various indications, including metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), urothelial carcinoma, hepatocellular carcinoma (HCC), and microsatellite instability-high (MSI-H).
Bristol-Myers Squibb oncology development head Fouad Namouni said: “Alongside our partner, Ono Pharmaceutical, we are proud to offer Opdivo as an alternative to chemotherapy for patients in Japan with esophageal cancer, regardless of their PD-L1 status.
“This first-ever approval of Opdivo in esophageal cancer exemplifies our commitment to advancing treatment options with the potential to extend survival for patients with difficult-to-treat gastrointestinal cancers.”
Opdivo is used as a treatment option for multiple cancers
According to the US-based company, oesophageal cancer ranks seventh among the most common cancer and is the sixth most common cause of cancer deaths across the world. The two most common types of esophageal cancer include adenocarcinoma and squamous cell carcinoma.
In addition, squamous cell carcinoma is said to account for approximately 90% of all esophageal cancer cases diagnosed in Japan, and most of the cases are diagnosed in the advanced stages.
Bristol-Myers Squibb said that the Phase 3 ATTRACTION-3 clinical trial, which evaluated Opdivo compared to chemotherapy comprising docetaxel or paclitaxel, has supported the Japanese regulatory approval for the drug.
The study has met the primary endpoint of overall survival (OS), reducing 23% risk of death and a 2.5-month improvement in median OS compared to chemotherapy, and the safety profile of Opdivo was consistent with previously reported studies in solid tumours.