Steven Lemery

TL;DR: The FDA approved pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

TL;DR: In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and pediatric patients with unresectable or metastatic, microsatellite-instability–high or mismatch-repair–deficient solid tumors, regardless of tumor site or histology.

TL;DR: There is evidence that treatment with TNF blockers in children may increase the risk of malignancy, but the cases were confounded by the potential risk ofmalignancy associated with underlying illnesses and the use of concomitant immunosuppressants; therefore, a clear causal relationship could not be established.

TL;DR: The FDA approved pembrolizumab on June 16, 2020, for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [TMB-H; ≥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 as discussed by the authors.

TL;DR: The data and analyses that led to the U.S. Food and Drug Administration approval of ofatumumab for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab are described.