Drugs

Antibody Drug Conjugate Guidance Explained

Dr. Qin Sun, biologics lead in the CDER Office of Clinical Pharmacology, says the agency developed the new guidance, Clinical Pharmacology Considerations for Antibody-Drug Conjugates, “to provide comprehensive clinical pharmacology recommendations for antibody-drug conjugates (ADCs).” Speaking on a Center Guidance Recap podcast, Sun said an ADC is generally composed of a small molecule drug, also known as a payload, and an antibody or antibody fragment, conjugated together by a chemical linker.

The guidance covers dosing strategies, bioanalytical approach, intrinsic factors, drug-drug interactions, and more to support the growing number of ADCs under development, Sun said.

She and Office of Clinical Pharmacology policy analyst Dr. Sarah Ridge used the podcast to discuss various aspects of the guidance.

Asked about unique considerations for the bioanalytical approach in ADC development, Sun said the assay needs to be validated as recommended in an International Council for Harmonization guidance. Second, she said, if the antibody’s target is shed into systemic circulation, the assay needs to distinguish the target-bound versus target-unbound ADC. And third, under certain scenarios, measuring some analytes may not be necessary.

Ridge said she and Sun hope podcast listeners gain an appreciation for the unique nature of the ADC. “We also hope they remember that a thorough understanding of the pharmacokinetics and pharmacodynamics of the ADC and its constituent parts early in development is crucial to inform dosing strategies later in development,” she said.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome