CHMP recommends approval of change of indication for Yervoy in advanced (unresectable or metastatic) melanoma.- BMS.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Yervoy (ipilimumab), from Bristol-Myers Squibb Pharma. The CHMP adopted a change to the existing indication as follows: Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older. Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.

Comment:The benefits with Yervoy are its ability to increase overall survival in patients with advanced (unresectable or metastatic) melanoma. The most common side effects are diarrhoea, rash, puritus, fatigue, nausea, vomiting, decreased appetite and abdominal pain. It was the first new melanoma treatment to extend survival in patients with advanced forms of the cancer.