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Antibody-drug conjugates built on the same linker and payload, such as deruxtecan or vedotin, share the same conjugation process, payload synthesis, impurity profile and much of the toxicology. FDA, EMA and PMDA should designate these linker-payloads as platforms so a new ADC files only antibody-specific manufacturing and toxicology data.
FDA's platform technology designation programme (draft guidance 2024, from the 2022 omnibus legislation) allows a well-characterised technology used in an approved product to be referenced in later applications. ADC linker-payloads (deruxtecan, vedotin, site-specific enzymatic conjugation from Synaffix or Araris) are natural platforms: the conjugation process, payload synthesis, impurity profile and much of the non-clinical toxicology are antibody-independent. The proposal is for FDA, EMA and PMDA to jointly designate ADC linker-payload platforms and publish what data may be referenced, so a new ADC on a designated platform files only antibody-specific CMC and toxicology.
Shares Payload (ADC), Manufacturing cost and time for living and radioactive medicines, Antibody-drug conjugate (ADC).
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).