NICE backs Opdivo as first immunotherapy for patients in England with OSCC

13 May 2021
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Today, the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) approving US pharma major Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) as the first immuno-oncology monotherapy for the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell cancer (OSCC) in England, in patients who have previously failed chemotherapy.

  • Nivolumab is the first immuno-oncology treatment to be approved in England for patients with unresectable advanced OSCC, regardless of biomarker presence;
  • The current primary cancer treatment for OSCC is chemotherapy, with 45% of patients receiving it as part of their curative or palliative cancer treatment;
  • The NICE recommendation is supported by three-year data from the Phase III ATTRACTION-3 study, demonstrating continued overall survival and a favourable safety profile with nivolumab compared to taxane chemotherapy; and
  • Overall survival rates of patients with nivolumab and CT were 20.2% and 13.5% at 24 months, and 15.3% and 8.7% at 36 months respectively.

Opdivo, which generated global sales of $7 billion in 2020, is already one of Bristol Myers top selling drugs and is approved in a number of cancers indications.

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