Danyelza: what was done before first-in-human, and what came after?

“The initial clinical trials investigating the activity and dosing of naxitamab were conducted on the basis of previous clinical data with the murine parent antibody rather than supported by toxicology data with the clinical candidate.”

“The initial clinical trials investigating the activity and dosing of naxitamab were conducted on the basis of previous clinical data with the murine parent antibody rather than supported by toxicology data with the clinical candidate.”

“A 13-Week Toxicity Study by Intravenous Infusion Administration to Hsd:RH-Foxn1rnu Nude Rats Followed by a 4-Week Recovery Period (YN70HM)”

“Rats received intravenous naxitamab for 4 cycles of 3 treatment days per cycle (every other day on Days 1, 3, and 5) at doses of 0, 10, or 50 mg/kg.”

“In addition, because the age of the proposed patient population is primarily ≤5 years old, FDA did not request an embryo-fetal development study to support the use of naxitamab.”

“Y-mAbs did not conduct dedicated studies to assess fertility or carcinogenicity and these studies are not warranted to support the development of a drug intended to treat patients with advanced cancer. In addition, because the age of the proposed patient population is primarily ≤5 years old, FDA did not request an embryo-fetal development study to support the use of naxitamab.”

“In addition, because the age of the proposed patient population is primarily ≤5 years old, FDA did not request an embryo-fetal development study to support the use of naxitamab.”

“Y-mAbs has not conducted carcinogenicity studies with naxitamab.”

“Y-mAbs has not conducted carcinogenicity studies with naxitamab. In accordance with ICH S6 and ICH S9, these studies are not considered necessary to support a marketing application for a biotechnology-derived pharmaceutical intended to treat advanced cancer.”

“Y-mAbs has not conducted carcinogenicity studies with naxitamab. In accordance with ICH S6 and ICH S9, these studies are not considered necessary to support a marketing application for a biotechnology-derived pharmaceutical intended to treat advanced cancer. The FDA’s Assessment: FDA agrees.”