BMS’ Opdivo sparks expert enthusiasm but also circumspection on FDA approval in HL

21 Apr 2016

Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) has potential to win FDA approval in classical Hodgkin's lymphoma (cHL) based on a Phase II study, experts said. Nonetheless, the lack of publicly available data and possible need for more patients left experts cautious.

Still, some experts said, the PD-1 checkpoint inhibitor's ability to induce remissions even in heavily pretreated patients and, therefore, its likelihood of showing successful results in the Phase II CheckMate 205 study (NCT02181738), bolster its approval chances. The label would probably be for patients who have received autologous stem cell transplant (SCT), they agreed, use a label indication for use after Seattle Genetics' (NASDAQ:SGEN) Adcetris (brentuximab vedotin) drew mixed sentiments.

The FDA has given priority review to BMS' sBLA in cHL, the company said in a 14 April press release, and this news service reported the same day that the PDUFA date was 1 September.

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