Bristol-Myers Squibb’s Opdivo recommended for EU approval in new indication

Bristol-Myers Squibb has announced that its drug Opdivo has been recommended for European regulatory approval in a new cancer indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo as a monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.

Data from CheckMate -141, a pivotal phase III trial, has demonstrated the overall survival benefits of Opdivo can deliver compared to methotrexate, docetaxel or cetuximab in the adjuvant, primary, recurrent or metastatic setting.

This is the first CHMP positive opinion to recommend a PD-1 inhibitor for this type of treatment for SCCHN. Opdivo is already approved by the European Commission for six indications across four distinct tumour types.

Emmanuel Blin, senior vice-president and chief strategy officer of Bristol-Myers Squibb, said: "Nearly half of all patients with squamous cell cancer of the head and neck relapse within two years of treatment and limited advancements have been made in the last ten years, underscoring the critical need for new treatment options."

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