BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates

On Monday, May 9^th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a regulatory guidance that is comprehensive yet adaptable, given the diversity and complexities of ADCs today. However, BIO noted that FDA’s inclusion of a broader range of ADC products in the final guidance would be valuable to sponsors and urged FDA to provide further detail when defining and referencing various components of ADCs and their byproducts. The comments also highlighted the current challenges sponsors face in considering the inclusion of organ impairment patients and patients with interacting concomitant medications, and requested the Agency provide additional guidance on when and how these patients should be included. Lastly, BIO encouraged FDA to provide additional examples and recommendations regarding the use of physiologically based pharmacokinetic (PBPK) modeling, and to consider opportunities where sponsors could leverage existing data on ADCs with the same linker-payload (if available).