Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community Home
          About FDA
          FDA Organization
          Oncology Center of Excellence
          Project OptimusOncology Center of Excellence Project Optimus
  
  					Reforming the dose optimization and dose selection paradigm in oncology
	
    Share
    Post
    Linkedin

    Email
    PrintImage
              Project OptimusPurpose

The Oncology Center of Excellence (OCE) Project Optimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Too often, the current paradigm for dose selection—based on cytotoxic chemotherapeutics—leads to doses and schedules of molecularly targeted therapies that are inadequately characterized before initiating registration trials.

Patients may be receiving these novel therapeutics for longer periods of time to maximize the benefit of a drug, which ideally includes not only longer survival but also an improved quality of life.

Poorly characterized dose and schedule may lead to selection of a dose that provides more toxicity without additional efficacy, severe toxicities that require a high rate of dose reductions, intolerable toxicities that lead to premature discontinuation and missed opportunity for continued benefit from the drug, and potentially persistent or irreversible toxicities that limit the options for receiving benefit of subsequent therapies—to name a few examples.

Goals

The goal of Project Optimus is to educate, innovate, and collaborate with companies, academia, professional societies, international regulatory authorities, and patients to move forward with a dose-finding and dose optimization paradigm across oncology that emphasizes selection of a dose or doses that maximizes not only the efficacy of a drug but the safety and tolerability as well.

Specific Goals include:

Communicate expectations for dose-finding and dose optimization, through Guidance, workshops, other public meetings
	Provide opportunities for and encourage drug developers to meet with FDA Oncology Review Divisions early in their development programs, well before conducting trials intended for registration, to discuss dose-finding and dose optimization.
	Develop strategies for dose finding and dose optimization that leverages nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. An emphasis of such strategies will be placed on performing these studies as early as possible in the development program and as efficiently as possible to bring promising new therapies to patients.Optimus leads are Drs. Mirat Shah and Atik Rahman, and a wide range of expertise is represented among the entire project team including medical oncologists, clinical pharmacologists, pharmacologists-toxicologists, statisticians.

Oncology Dosing Tool Kit

A resource to support stakeholders in their decision-making regarding dosage optimization.

Publications

Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients. Fourie Zirkelbach J, Shah M, Vallejo J, Cheng J, Ayyoub A, Liu J, Hudson R, Sridhara R, Ison G, Amiri-Kordestani L, Tang S, Gwise T, Rahman A, Pazdur R, Theoret MR. J Clin Oncol. 2022 Sep 12:JCO2200371.
	How to Get the Dose Right. The ASCO Post. Mirat Shah, Atiqur Rahman, Marc R. Theoret, and Richard Pazdur. May 10, 2022.
	Optimizing Dosing in Oncology Drug Development Q&A. Friends of Cancer Research. April 7, 2022. Shah M, Rahman A, Theoret MR, Pazdur R.
	The Drug-Dosing Conundrum in Oncology - When Less Is More. N Engl J Med. 2021 Oct 14;385(16):1445-1447. doi: 10.1056/NEJMp2109826. Epub 2021 Oct 9. PMID: 34623789.
	Friends of Cancer Research White Paper. Optimizing Dosing in Oncology Drug Development. Friends of Cancer Research Annual Meeting 2021.FDA Guidance and Other Materials

ODAC Pediatric Oncology Subcommittee meeting on dosage optimization in pediatric drug development, June 16, 2023
	Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (draft guidance, January 2023)
	Population Pharmacokinetics
	Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
	ICH Topic E4: Dose-Response Information to Support Drug RegistrationFurther Information

Oncology Center of Excellence

                                                                                  Content current as of:
      01/05/2024Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop