Leqselvi: which risks did reviewers probe?

“The target organs were identified as lymphoid organs in both species, with major study findings including reduced circulating white blood cells and lymphocytes and decreased lymphocytes/cellularity in various lymphoid tissues (including spleen, thymus, lymph nodes, and gut-associated lymphoid tissue).”

“Milk/plasma concentration ratios were approximately 7, 13, 19, and 20 at 1 hr, 2 hr, 4 hr, and 8 hr postdose, respectively.”

“The major safety signals identified in these studies were consistent with deuruxolitinib’s pharmacological activity. The target organs were identified as lymphoid organs in both species, with major study findings including reduced circulating white blood cells and lymphocytes”

“Deuruxolitinib is a small molecule that is not expected to be associated with immunogenicity. Therefore, the Applicant did not assess the potential for antibody formation.”