FDA has accepted supplemental Biologics License Application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.
