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Home Industry News Bristol-Myers Squibb’s Opdivo achieves EU regulatory milestones

Bristol-Myers Squibb’s Opdivo achieves EU regulatory milestones

4th April 2016

Bristol-Myers Squibb has announced that its cancer therapy Opdivo has achieved two key regulatory milestones in Europe.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced melanoma in adults.

Additionally, the committee added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival for this combination is established only in patients with low tumour PD-L1 expression.

Dr Jean Viallet, global clinical research lead for oncology at Bristol-Myers Squibb, said: "We continue our progress in finding new treatment options for this devastating disease through the study of the combination of these two immuno-oncology agents."

Meanwhile, it has also been announced that the European Medicines Agency has agreed to review the company's application to extend the current indications for Opdivo to include the treatment of patients with classical Hodgkin lymphoma after prior therapies.

This is because adult relapsed and refractory classical Hodgkin lymphoma patients currently have limited remaining treatment options available to them.ADNFCR-8000103-ID-801815859-ADNFCR

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