… locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC) is a
serious and life‐threatening disease. Squamous cell cancers of the head and neck are …

… Union (EU)‐approved cetuximab rather than US‐approved cetuximab. US‐approved
cetuximab provides approximately 28% higher exposure relative to EU‐approved cetuximab in a …

… a head-to-head comparison against an FDA approved therapy… However, in this head-to-head
“replacement” design, FDA … trial results to the post-approval population, many of whom will …

… for B-cell chronic lymphocytic leukemia (B-CLL). Alemtuzumab was initially approved in
2001 under accelerated approval regulations. Conversion to regular approval was based on a …

… antibodies (mAbs) targeting the same receptor or its ligand have been approved for use
in oncology. However, no studies have summarized head-to-head trials of these mAbs. …

… clinical effectiveness of the CAR T‐cell therapy by blocking T‐cell activation, function, and
… supported the approval of tocilizumab for treatment of severe or life‐threatening CAR T cell‐…

… provides a summary of all CAR T-cell therapies approved by … not intend to make a head-to-head
comparison between products; … principles in the approval of CAR T-cell products to date. …

… approved in 2017 for adult patients with r/r large B-cell … CAR T-cell therapies also have
been approved for other … leukemia and, most recently, mantle cell lymphoma), but until recently …

… Drug Administration (FDA) approved brentuximab vedotin (BV… cell lymphoma or other
CD30‐expressing peripheral T‐cell … FDA clinical review and basis of approval of BV+CHP as a …

… who require therapy for associated renal cell carcinoma (RCC), … The FDA granted approval
based on the clinically meaningful … tumor size is ≥2 cm in the head of the pancreas or ≥3 cm …