Bristol-Myers Squibb receives CHMP backing for new EU Opdivo approval

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

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.

This recommendation is based on positive findings from the phase II CheckMate-205 and the phase I CheckMate-039 trials, showing the strong response rates associated with the drug in this patient group.

If approved, Opdivo will become the first PD-1 inhibitor available for the treatment of a haematologic malignancy in the EU.

Emmanuel Blin, senior vice-president and chief strategy officer at Bristol-Myers Squibb, said: "Today's CHMP positive opinion marks an important milestone in applying our immuno-oncology science to delivering a treatment option for patients with this haematologic malignancy."

Opdivo is currently approved in more than 57 countries, with its clinical development programme having enrolled more than 25,000 patients to date.

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