Opdivo nivolumab regulatory update

The European Commission approved Opdivo nivolumab from Bristol-Myers Squibb to treat locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy. Additionally, EMA accepted for review 2 parallel Type II variation applications seeking to extend Opdivo’s label to include its use as a monotherapy to treat locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults and its use in combination with Yervoy ipilimumab to treat unresectable or metastatic melanoma in adults. Last month, the EC approved the human IgG4 mAb against PD-1 to treat unresectable or metastatic melanoma in adults, regardless of BRAF status.

Separately, Ono submitted an application in Japan for Opdivo to treat unresectable, advanced or recurrent NSCLC, including non-squamous NSCLC. In April, Ono submitted an application in the country for Opdivo to treat unresectable, advanced or recurrent squamous NSCLC. The drug is approved in Japan to treat unresectable melanoma. ...