FDA Accepts sBLA For BMS’ Opdivo for Classical Hodgkin LymphomaBy
The US Food and Drug Administration (FDA) has accepted a supplemental bologics license application (sBLA) for Bristol-Myers Squibb’s Opdivo (nivolumab) to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The FDA granted the application a priority review and previously had granted Opdivo breakthrough therapy designation for cHL in May 2014. According to the FDA, breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
Opdivo is approved as single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. It is approved in 48 countries, including the United States, Japan, and in the European Union.
It is also approved for the treatment of patients with metastatic non-small cell lung cancer as well as advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
Source: Bristol-Myers Squibb