Affiliation:
1. Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences US Food and Drug Administration Silver Spring Maryland USA
2. Division of Oncology I, Office of Oncologic Diseases Office of New Drugs, CDER, US Food and Drug Administration Silver Spring Maryland USA
Abstract
Optimized dosages provide a secure foundation for the development of well‐tolerated and effective oncology drugs. Project Optimus, an initiative within the Oncology Center of Excellence, strives to reform the dosage optimization and dosage selection paradigm in oncology. This initiative stems from the availability of targeted drugs and from the demand for more tolerable dosages from patients, caregivers, and advocates. Reforming dosage optimization for oncology drugs requires a paradigm shift from the one employed for cytotoxic chemotherapy to one that understands and considers the unique attributes of targeted therapy, immunotherapy, and cellular therapy. Limited characterization of dosage during drug development may result in (1) patients not staying on a therapy long‐term due to poor tolerability, (2) failure to establish positive benefit–risk in clinical trials for regulatory approval (3) withdrawal of drugs from the market (4) removal of indications of drugs from the market. Timely access to drugs is important for all patients with cancer, so it is vital to iteratively analyze all nonclinical and clinically relevant data at each stage of development and leverage quantitative approaches, innovative trial designs, and regulatory support to arrive at dosages with favorable benefit–risk. This review highlights the key challenges and opportunities to embracing this new paradigm and realizing the full potential of new oncology therapies.
Reference105 articles.
1. Bates B.First FDA‐approved chemo agent turns 60.Internal Medicine NewsMarch 1 2009.
2. Initial sequencing and analysis of the human genome
3. The Institute of Cancer Research.How the human genome project shook the world of cancer research.
4. Drugs@FDA: FDA‐Approved Drugs.Trastuzumab.
5. Drugs@FDA: FDA‐Approved Drugs.Imatinib Mesylate.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献