The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB)≥ 10: a decision centered on empowering patients and their …
On 16 June 2020, the US Food and Drug Administration (FDA) granted accelerated
approval to pembrolizumab for the treatment of 'adult and pediatric patients with
unresectable or metastatic tumor mutational burden-high (TMBH)[10 mutations/megabase
(mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed
following prior treatment and who have no satisfactory alternative treatment options'. 1 This
approval was based on efficacy data from 10 refractory solid tumor cohorts enrolled in a …
approval to pembrolizumab for the treatment of 'adult and pediatric patients with
unresectable or metastatic tumor mutational burden-high (TMBH)[10 mutations/megabase
(mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed
following prior treatment and who have no satisfactory alternative treatment options'. 1 This
approval was based on efficacy data from 10 refractory solid tumor cohorts enrolled in a …