Yervoy ipilimumab regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Yervoy ipilimumab from Bristol-Myers Squibb has "no additional benefit" vs. chemotherapeutic dacarbazine for previously untreated patients with unresectable or metastatic melanoma - an indication the European Commission approved in November. IQWiG said data submitted by the company were "not interpretable" because of uncertainty associated with BMS's indirect comparison of Yervoy and dacarbazine, the comparator requested by Germany's Federal Joint Committee (G-BA), along with the pharma's exclusion of data for patients with a "particularly poor" prognosis who had received Yervoy. Comments are due April 7, with a final assessment from G-BA expected in early June.

BMS already markets Yervoy in Germany for second-line melanoma at an undisclosed price negotiated with the Statutory Health Insurance Funds Association (GKV-Spitzenverband) (see BioCentury, Feb. 11, 2013). In 2012, G-BA said the human mAb against CTLA-4 receptor has "significant" additional benefit over best supportive care in patients with advanced malignant melanoma who have received previous therapy (see BioCentury, Aug. 6, 2012). ...