FDA approves Opdualag for unresectable or metastatic melanoma
Click Here to Manage Email Alerts
The FDA approved relatlimab plus nivolumab for treatment of patients aged 12 years or older with unresectable or metastatic melanoma.
The combination, which will be marketed as Opdualag (Bristol Myers Squibb), is a first-in-class, fixed-dose dual immunotherapy combination treatment comprised of the PD-1 inhibitor nivolumab (Opdivo, Bristol Myers Squibb) and the novel lymphocyte activation gene-3 (LAG-3)-blocking antibody relatlimab (Bristol Myers Squibb).
The FDA based the approval on results of the randomized, double blind, phase 2/phase 3 RELATIVITY-047 trial, which compared relatlimab and nivolumab with standard nivolumab monotherapy.
As Healio previously reported, results showed the combination more than doubled median PFS (10.1 months vs. 4.6 months; HR = 0.75; 95% CI, 0.62-0.92).
The safety profile of the combination appeared consistent to that previously reported for nivolumab monotherapy.
“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” F. Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute, said in a Bristol Myers Squibb-issued press release. “[This] approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.”
Read more about
Click Here to Manage Email Alerts