ARTICLE | Clinical News
Opdivo nivolumab regulatory update
November 16, 2015 8:00 AM UTC
EMA accepted for review a Type II variation application from Bristol-Myers Squibb seeking to expand the label of Opdivo nivolumab to include the treatment of adult patients with advanced renal cell carcinoma (RCC) after prior therapy. The submission is based on data from the Phase III CheckMate -025 trial (see BioCentury, Oct. 5).
In the EU, the human IgG4 mAb against PD-1 is approved as monotherapy for advanced melanoma. In September, EMA’s CHMP recommended expanding Opdivo’s label to include locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy. ...