EMA Begins Review of New Use for BMS’s Cancer Drug OpdivoBy
The European Medicines Agency (EMA) has validated a Type II variation application, which seeks to extend the current indications for Bristol-Myers Squibb’s immunotherapy, Opdivo (nivolumab) to include the treatment of patients with classical Hodgkin lymphoma (cHL) after prior therapies. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.
Opdivo is approved in several other cancer indications. It is approved as a single agent for treating patients with BRAF V600 wild-type unresectable or metastatic melanoma. It is alos indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) for treating patients with unresectable or metastatic melanoma. It is also approved to treat metastatic non-small cell lung cancer and for advanced renal cell carand fcinoma (RCC) who have received prior anti-angiogenic therapy.
Source: Bristol-Myers Squibb