Bristol-Myers Squibb’s Yervoy scores EU approval in paediatric melanoma
pharmafile | January 23, 2018 | News story | Manufacturing and Production, Sales and Marketing | BMS, Bristol-Myers Squibb, EU, Yervoy, pharma
Bristol-Myers Squibb has revealed that its immunotherapy Yervoy (ipilimumab) has received an expanded indication from the European Commission, approving the drug for use in the European Union in the treatment of advanced (unresectable or metastatic) melanoma in paediatric patients 12 years of age and older.
The decision arose on the back of trial data generated in two clinical trials: a dose-finding study examining 33 patients with relapsed or refractory solid tumours aged between two and 21, and a second study involving 12 patients between the ages of 12 and 16 with previously treated or untreated, unresectable Stage III or IV malignant melanoma.
“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,” said Fouad Namouni, Head of development, Oncology, at BMS. “With this approval, we’re able to provide an alternative to young patients whose treatment options have traditionally been limited.”
Meanwhile, Peter Mohr, Chief Physician for the Department of Dermatology at Elbe Klinikum Buxtehude and head of Skin Cancer Center Buxtehude, added: “While paediatric melanoma is rare, more effective therapeutic approaches are needed for this patient population. This approval of Yervoy in the EU expands physicians’ options for paediatric patients with advanced melanoma to include an Immuno-Oncology treatment.”
This latest approval follows the marketing authorisation awarded by the FDA in the same indication in July 2017.
Matt Fellows
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