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Home Industry News Bristol-Myers Squibb’s Yervoy recommended by CHMP for paediatric melanoma

Bristol-Myers Squibb’s Yervoy recommended by CHMP for paediatric melanoma

19th December 2017

Bristol-Myers Squibb has announced that its cancer drug Yervoy has been recommended for EU approval as a new therapy for paediatric melanoma.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Yervoy for paediatric patients aged 12 years and older who have unresectable or metastatic melanoma.

This drug has been evaluated in two trials of paediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumours, and an open-label, single-arm trial in 12 adolescents with previously treated or untreated unresectable stage III or IV malignant melanoma.

The US Food and Drug Administration has already expanded the approval of Yervoy to include paediatric patients in July 2017, with a similar decision now expected from the European Commission.

Murdo Gordon, executive vice-president and chief commercial officer at Bristol-Myers Squibb, said: "We are pleased with today's positive CHMP opinion and look forward to hearing from the European Commission, as we continue to develop and deliver new therapies for the paediatric cancer community."

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