The FDA’s Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific expertise to accelerate the review and approval of drugs, biologics, and medical devices for cancer care. As the oncology landscape continues to evolve, the OCE aims to improve access to safe, effective, and cutting-edge therapies through streamlined regulatory processes and patient-centered approaches.

In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development.

Determining a new product’s pathway

The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies. Instead, sponsors must submit applications to the appropriate product center (CDER, CDRH or CBER), which then determines whether the product will be under an expedited program with involvement of the OCE in reviews. For some products, the OCE may form a Medical Oncology Review and Evaluation (MORE) team, including a medical oncologist and specialists from the relevant product center. The MORE team provides a unified clinical review of the program, while the product center makes the final approval determination, considering both clinical and non-clinical information holistically.

The FDA’s expedited programs are intended to facilitate and advance the development and review of new drugs and biologics to address unmet medical needs in the treatment of serious or life-threatening conditions, such as cancer. These include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and the Accelerated Approval Pathway (AAP). The AAP is inherently associated with the OCE, as cancer drugs account for about 85% of all accelerated approvals granted in the past decadeⁱ. These reviews have provided life-saving cancer therapies a median of 3.1 years before they would have been available otherwiseⁱⁱ.

Creating a path to transparency 

To broadly disseminate the FDA’s latest thinking for streamlining approvals in oncology, Richard Pazdur, the OCE founding director, and his team, have developed multiple collaborative programs and educational initiatives that are available to all, including industry, academia, and patients and families. These resources provide accurate and current strategies that strongly represent FDA’s standpoint and have routinely been leveraged by Premier’s team of strategists when guiding sponsors through their development plans. The summary presented in the table below features some of these initiatives.

Program	What is it?	Main Goals
Community Resources
Conversations on Cancer	A public panel discussion series	Discuss cancer-related social issues with inclusive and diverse panel members from the US and within the FDA.
Project Community	A public health outreach initiative	Improve communication between medically underserved communities nationwide and medical professionals to foster greater health awareness, reduce cancer risk, and increase survival.
Healthcare Professional Resources
Project Socrates	An educational network	Build an educational network bridging the OCE and the public, focusing on regulatory policy and science. Offers fellowship programs and workshops, on-demand learning, and lecture series.
Project Facilitate	A single point of contact call and information	Help oncology healthcare providers or regulatory professionals with submitting an Expanded Access Request through FDA’s Expanded Access Program for an individual cancer patient.
Oncology Regulatory Affairs and Policy Program
Advancing Oncology Decentralized Trials	Multiple trial modernization initiatives	Evaluate the benefits and challenges of decentralized trials to prioritize streamlined procedures for future trials.
Project Confirm	An initiative for transparency of accelerated approval outcomes	Enhance the balance of access and verification of clinical benefit for therapies available to patients with cancer and hematologic malignancies. Provides the Oncology Accelerated Approvals Database.
Pediatric and Rare Cancers
Pediatric Oncology Program	An initiative for development of new products to treat pediatric patients	Maximize the authority of the Best Pharmaceuticals for Children Act (BPCA) to increase the number of requests for pediatric studies of new drugs developed for adult cancers much earlier in the development timeline.
Rare Cancers Program	An initiative for development of new products to treat rare cancers	Leverage multiple OCE projects and initiatives that address the challenges of developing new treatments for cancers that affect a small number of patients.
Clinical Regulatory Projects
Project Optimus	An initiative to reform the dose selection paradigm in oncology drug development	Encourage and provide opportunities for 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. Provides the Oncology Dosing Toolkit.
Project Frontrunner	An initiative for the development of new therapies to the early clinical setting	Develop a framework for identifying drug candidates that are appropriate to initially develop for early metastatic disease (e.g., first or second line setting), considering clinical, scientific, regulatory, and operational factors.
International Projects
Project Orbis	An initiative for collaboration among international regulators	Provide a framework for concurrent submission and review of oncology products among international partners, including Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK. Sponsors can request Project Orbis for their applications.
Project Asha	An initiative to increase cancer clinical trial access in India	Identify short- and long-term opportunities for bilateral cancer cooperation that will drive greater care and improved outcomes for cancer patients.
Research and Development Projects
Project Pragmatica	An initiative to advance evidence generation for approved products	Introduce functional efficiencies and enhance patient centricity by integrating aspects of clinical trials with real-world routine clinical practice through appropriate use of pragmatic design elements.
Project 5 in 5	A crowdsourcing initiative	Identify 5 clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, over the next 5 years. Resulting ideas will be shared with those interested in implementing them.

 

Leveraging the appropriate resources for your program

Most of the initiatives listed above propose a framework to foster innovation and enhanced engagement with the FDA; however, there is not a “one size fits all” approach for how one or many of these resources will be rolled into the context of a specific program. If you are a sponsor developing a new cancer treatment, the general recommendation is to engage in early conversations with the FDA to discuss your proposed program and how it could benefit from OCE initiatives. Premier Consulting can help you through the process, ensuring that your strategy is aligned with these frameworks, and provide support through all phases of your oncology product development. To learn more about drafting and implementing an effective diversity action plan, contact us.

 

REFERENCES:

[i] OCE, 2023b. Project Confirm: Promoting the transparency of Accelerated Approval for oncology indications and Fashoyin-Aje et al., 2022. The On- and Off-Ramps of Oncology Accelerated Approval

[ii] OCE, 2023b. Project Confirm: Promoting the transparency of Accelerated Approval for oncology indications