RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsJune 27, 2024 - FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody-drug conjugate (ADC) patritumab deruxtecan.
The FDA’s complete response letter is related to problems found during an inspection of a contractor’s manufacturing facility, rather than any issues with the efficacy or safety data, the two firms said.
This issue with the contractor's manufacturing capabilites demonstrates the complexity of the antibody-linker-payload structure of antibody-drug conjugates and the overall difficulty of manufacturing ADCs, without the ADC structure being compromised.
Then of course, there is the issues of safety and effectivenes of the ADCs once administered to the patient, which are relative to the linker's reliability, and the payload's side effect profile and dosing limitations.
https://www.fiercepharma.com/pharma/daiichis-lung-cancer-adc-rejected-fda-blow-first-project-under-merck-partnership