The European Medicines Agency has reversed its decision against nivolumab (Opdivo) with ipilimumab (Yervoy) for the treatment of renal cell carcinoma (RRC).
In July, the EMA’s Committee for Medicinal Products for Human Use (CHMP) rejected an application to extend the authorisation of nivolumab to include combined treatment with ipilimumab for RCC. However, at the request of the company, the CHMP re-examined its opinion and adopted a final positive opinion at its meeting last week, but requested the company to conduct a study to collect further data.
As well as being approved as monotherapy for the treatment of advanced RCC after prior therapy, nivolumab is now approved with ipilimumab for the first-line treatment of intermediate/poor-risk advanced RCC.
Originally, the CHMP concluded that the clinical evidence submitted by the company, which compared the combination treatment with sunitinib, showed improved survival with nivolumab plus ipilimumab but did not demonstrate that ipilimumab contributed to the result.
During the re-examination, the CHMP reviewed all the data, including studies in other cancers, and consulted an expert group of clinicians and patients. Although the precise contribution of ipilimumab was not clear, the CHMP considered that the benefit of ipilimumab in combination with nivolumab has been sufficiently demonstrated.