Irinotecan—A Case Study for the Transition from Accelerated Approval to Traditional Approval

Mannix, Daniel G.

doi:10.1177/009286150003400309

Cited by 1 publication

(1 citation statement)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, no guidelines have been developed for use of TTP or other Level-3 biomarkers in clinical trials with cytostatic compounds despite the interest expressed by some regulators (Johnson et al, 2003). Historically, drugs receiving provisional approval have gained an average of 27 months on market, based on the elapsed time from accelerated to full approval (Mannix, 2000). However, the increased productivity gained through accelerated approvals could soon be lost if surrogate endpoints appropriate for assessing targeted cancer therapy are not developed as swiftly as possible, which remains one of the most pressing problems in current oncology drug development (Dancey et al, 2003).…”

Section: Use and Adaptation Of Conventional Clinical Assaysmentioning

confidence: 99%

Development and Use of Biomarkers in Oncology Drug Development

Floyd

McShane

2004

Toxicol Pathol

View full text Add to dashboard Cite

Successful development and use of biomarkers will improve the productivity of oncology drug development. Recognition of the importance of biomarkers for speeding drug development is reflected in the precise definitions and concepts proposed by an NIH Working Group to standardize terminology and promote a more coherent and systematic approach to the development and use of biomarkers. Potential clinical biomarkers of drug efficacy are often identified through pre-clinical studies or basic research. Identification of potential biomarkers for use in oncology is moving rapidly forward through continuing advances in clinical imaging technologies, especially molecular and functional imaging. Other rapid advances are a product of the growing availability of new scientific reagents for established technologies and of high-throughput genomic and proteomic technologies that can generate hundreds of potential biomarkers for further evaluation. In certain cases, conventional clinical diagnostic techniques or assays can be adapted for use in pre-clinical models to evaluate their ability to serve as biomarkers for predicting clinical responses to new drug candidates. Evaluation (pre-clinical and clinical) of a potential biomarker is often the longest stage of biomarker development, and standards for evaluation or validation depend on the intended use and stage of clinical development. Biomarkers verified for use in preclinical studies can be used to help select appropriate animal models and lead compounds. Biomarkers verified for use in clinical trials can confirm a drug's pharmacological or biological mechanism of action, guide protocol design, aid patient and dose selection, and help to minimize safety risks. Oncology drug development can be optimized by using a tiered set of clinical biomarkers that predict compound efficacy and safety with increasing confidence at each rise in tier thereby aiding corporate decision-making about advancing compounds. In oncology, a special class of extensively evaluated biomarkers of efficacy (surrogate endpoints) that generally correlate with desired clinical outcomes can be used as a basis for corporate decisions as well as for gaining accelerated provisional regulatory approval of a drug.

show abstract

Section: Use and Adaptation Of Conventional Clinical Assaysmentioning

confidence: 99%