The market for antibody-drug conjugates, or ADCs, is hotter than ever before. In response, the Food and Drug Administration (FDA) released new guidance on clinical pharmacology considerations for ADCs, EndPoints News reports. Read on to find out more about the new guidelines on ADC pharmacology, as well as what the guidelines mean for research organizations and drug companies.
What Are ADCs?
Antibody-drug conjugates, or ADCs, are highly targeted biopharmaceutical drugs that are primarily used to treat cancer. These drugs combine monoclonal antibodies with potent anti-cancer agents, which makes them extremely effective against certain types of tumor cells. Currently, 12 ADCs for various cancer targets have FDA approval, and several others are coming to market soon.
New FDA Guidance on ADCs
As major drug companies like Seagen and J&J invest in ADCs, the FDA saw fit to establish updated guidelines for ADC pharmacology. In an announcement published in February, the agency wrote that developing ADCs “requires careful consideration of the differences between the clinical pharmacology of the antibody or antibody fragment and the small molecule.” The agency continued: “Therefore, selection of optimal dosing strategies for ADCs requires careful consideration of the differences between the pharmacokinetics (PK) and pharmacodynamics (PD) of the antibody and the payload.” In other words, ADCs will now require a more stringent evaluation process during first-in-human clinical studies to ensure safety and efficacy.
Implications of New Guidance on ADC Pharmacology
The FDA’s new 10-page draft guidance will have several implications for clinical trial researchers and drug companies. With that in mind, at the time of the announcement, affected companies were given 90 days to comment on the draft guidance. The draft guidance includes the following stipulations:
- The FDA now “strongly encourages broad dose-ranging in first-in-human studies for ADCs.”
- The agency also suggests selecting multiple-dose levels for evaluation in early clinical development, which will contribute to the safety and activity of each ADC.
- The FDA is also focusing more closely on labeling instructions for use in specific patient subsets. For example, as explained in EndPoints News, “Labeling recommendations could include avoiding dosing in a specific population where adverse events are expected to increase in severity and frequency in comparison to the overall population.” However, in those cases, drug companies should be advised that the dosage likely cannot be adjusted without adversely impacting efficacy.
The draft guidance also addresses other aspects of ADC development, such as the FDA’s current thinking on bioanalytical methods, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions. Ultimately, this guidance will help guide the safety and efficacy of these powerful drugs. This new guidance is just one example of how drug companies, clinical trial organizers, and regulatory agencies work together to create much-needed drugs for serious illnesses.
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