Posted by Michael Wonder on 17 Jun 2020
FDA approves pembrolizumab for adults and children with TMB-H solid tumours
17 June 2020 - On 16 June 2020, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumours, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Today, the FDA also approved the FoundationOneCDx assay (Foundation Medicine) as a companion diagnostic for pembrolizumab.
