CHMP Recommends Approval of Nivolumab/Ipilimumab Combo for Melanoma

Source: OncLive, April 2016

The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), which suggests that the treatment is likely to gain European approval for patients with advanced melanoma.

The positive opinion was based on the collection of data from the CheckMate-069 and -067 studies and a phase Ib trial. In the studies, the combination significantly improved objective response rates (ORR) and progression-free survival (PFS) versus monotherapy with ipilimumab for patients with advanced melanoma. In the CHMP opinion, the combination also improved PFS versus single-agent nivolumab, but only in patients with low tumor expression of PD-L1.

The company developing the combination, Bristol-Myers Squibb, noted that the European Commission, which is expected to make a decision within the coming months, was now reviewing the Marketing Authorization Application. If approved, nivolumab and ipilimumab would become the first immunotherapy combination available in the European Union.