On 11 December 2025, Bristol Myers Squibb announced that the FDA has granted priority review to its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine chemotherapy for adult and paediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 8 April 2026.
Recent new indication approvals for Opdivo® have generally been for treatments in combination with Yervoy® (ipilimumab) including for:
- Colorectal cancer in Australia, Canada, Europe, Japan, USA; and
- Hepatocellular carcinoma in Canada, Europe, Japan, Korea, Taiwan,
Previous approvals in combination with chemotherapy include for:
- Non-small cell lung cancer in Australia, Europe, USA;
- Urothelial carcinoma in Taiwan, USA; and
- Gastric, gastroesophageal junction or oesophageal adenocarcinoma in
A number of nivolumab biosimilars are under development including Xbrane/Intas’ Xdivane, Amgen’s ABP 206, Reliance Life Science’s RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276. In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.