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BMS scores first oesophageal cancer nod for Opdivo in Japan

Approval in Japan comes before US okay

Bristol-Myers Squibb

Bristol-Myers Squibb has won its first approval for Opdivo in oesophageal cancer, with an approval in Japan coming before a nod in the US. 

Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Opdivo (nivolumab) as a treatment of patients with unresectable advanced, or recurrent oesophageal cancer that has progressed after chemotherapy treatment.

The approval in oesophageal cancer is particularly important for BMS as it continues to fight for its place in the PD-1/L1 inhibitor class, while Merck & Co’s Keytruda (pembrolizumab) continues to take much of the market share.

With approximately 20,000 new cases of oesophageal cancer diagnosed in Japan each year, and 12,000 deaths, the Opdivo approval not only opens a significant market for BMS, but also offers a new treatment option for a disease which often has a poor prognosis.

The MHLW approved Opdivo based on the results from the phase 3 ATTRACTION-3 trial, which evaluated the PD-1 inhibitor versus chemotherapy – docetaxel or paclitaxel – as a treatment for patients with unresectable advanced or recurrent oesophageal squamous cell carcinoma (ESCC), which did not respond to or was intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.

Opdivo met the primary endpoint of overall survival (OS), demonstrating a 23% reduction in the risk of death and a 2.5 month improvement in OS when compared to chemotherapy. The survival benefit with Opdivo treatment was observed regardless of tumour PD-L1 expression levels.

BMS’ drug has already  received approval for the treatment of a number of cancer types, including mealnoma, small cell lung cancer, renal cell carcinoma and more.

It has also gained a number of approvals as of late in combination with CTLA4 blocker Yervoy (ipilimumab), as BMS continues to strengthen its Opdivo franchise against a myriad of competitors.

That includes Keytruda, Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (druvalumab) and Sanofi’s latecomer Libtayo (cemiplimab).

Despite being the first checkpoint inhibitor to reach the market back in 2015, Opdivo has continued to lose ground to rival Keytruda thanks to the latter drug's dominance in non-small cell lung cancer, which has put it on track to become the biggest selling drug by 2024, according to GlobalData.

“This first-ever approval of Opdivo in oesophageal cancer exemplifies our commitment to advancing treatment options with the potential to extend survival for patients with difficult-to-treat gastrointestinal cancers,” said Fouad Namouni, head, oncology development, BMS.

Article by
Lucy Parsons

24th February 2020

From: Regulatory

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