Columvi: genotox, carcinogenicity and repro: done or skipped?

“genotoxicity studies have not been conducted with glofitamab. It is not expected that glofitamab would interact directly with DNA or other chromosomal material.”

“Carcinogenicity studies with glofitamab have not been conducted and are not planned. Glofitamab is intended for the treatment of patients with advanced cancer.”

“While no animal studies were conducted to assess the reproductive and developmental risks of glofitamab, a weight of evidence (WoE)-based risk assessment report was submitted.”

“No specific safety pharmacology studies have been conducted with glofitamab. Effects on the central nervous, respiratory, and cardiovascular systems were evaluated in repeat-dose toxicity studies in cynomolgus monkeys.”