Bristol-Myers Squibb received EU approval for Yervoy in paediatric melanoma

Bristol-Myers Squibb has received European regulatory approval for a new indication of Yervoy that will allow the drug to be used as a treatment for paediatric melanoma.

The European Commission has expanded the indication of Yervoy to include the treatment of advanced melanoma in paediatric patients 12 years of age and older, marking Bristol-Myers Squibb's first immuno-oncology agent to be approved for paediatric use.

Yervoy has demonstrated its efficacy and safety in paediatric and adolescent patient populations across two clinical trials, including a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors, and an open-label, single-arm trial in 12 adolescents with advanced Stage III or IV malignant melanoma.

Dr Fouad Namouni, head of oncology development at Bristol-Myers Squibb, said: "The expanded EU indication of Yervoy for paediatric patients with unresectable or metastatic melanoma is an outcome of Bristol-Myers Squibb's unyielding commitment to advancing treatments for patients with unmet clinical needs."

This comes after the US Food and Drug Administration approved Yervoy to treat paediatric patients aged 12 years and older with unresectable or metastatic melanoma in July 2017.

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