How Prepared Is Your Oncology Team for Their FDA Advisory Committee Meeting?
Explore essential strategies that oncology product developers need to effectively prepare teams for FDA Ad Comm meetings and navigate processes to advocate oncology assets successfully.
For oncology development teams navigating the critical phase of bringing a new asset to market, mastering the intricacies of Federal Drug Administration (FDA) Advisory Committee (Ad Comm) meetings is paramount. These meetings are pivotal in assessing a product's safety and efficacy and significantly influence the FDA's decision-making process.
Advisory Committees provide independent expert advice on a range of complex issues, including new drug evaluations. Comprised of experts from fields such as medicine and statistics, and often including patient advocates, these committees are critical. A recent study from the Milbank Quarterly estimates that the FDA follows Ad Comm recommendations nearly 78% of the time. All oncology approvals must go through a specific committee for cancer-related assets known as the Oncologic Drugs Advisory Committee (ODAC).
Navigate FDA Ad Comms with our experts in Risk and Program Management.
The stakes are high, whether for seasoned experts accustomed to these rigorous meetings or new teams navigating their first Ad Comm. John West, an FDA Ad Comms expert and Managing Director of Consulting in the Risk and Program Management Advisory Group at Syneos Health, emphasizes, “Comprehensive preparation is key. It goes beyond having ready answers—it involves a strategic review of all possible scenarios, ensuring that your team can effectively handle unexpected developments.”
West and his team at Syneos Health have successfully guided numerous teams through the FDA Ad Comm maze, charting a path that balances thoughtful strategic preparation with meticulous tactical execution. “Initiate the preparation process well in advance by defining a clear communication strategy that can be refined through the preparation process,” advises West. “This aligns the briefing document, presentation and all question-and-answer materials, providing a cohesive and consistent narrative to address the topics that FDA has placed in front of the Advisory Committee.”
To that end, West and his team have identified the most vital strategies oncology teams can adapt when looking to prepare their asset for an FDA Ad Comm meeting.
The Keys to Ad Comm Success? Think Strategically in Order to Act Tactically
- Start Early to Stay on Time: While conventional wisdom suggests engaging in Ad Comm preparation three to six months prior to a potential meeting, considerations on whether the FDA will require an Ad Comm and, if so, what issues the agency might seek to address should start long before FDA provides a notification of the meeting. For oncology teams, this includes early discussions about the therapeutic indication, patient population and potential safety concerns specific to cancer treatments.
- Develop and Adhere to a Clear, Focused Strategy: Pivotal clinical trials are designed with a label in mind. Ad Comm strategy should do the same. Whether seeking specific labeling, designing a REMS, or negotiating post-marketing requirements, Ad Comm strategy should target specific outcomes. In oncology, this often means focusing on endpoints like progression-free survival, overall survival, and response rates. Tailor your strategy to address these endpoints clearly, showing how your product meets or exceeds current standards of care.
- Embrace the Process: Even with a wide preparation window, there is a world of work to be done creating materials that need to be coherent and coordinated, as well as training your team to flawlessly present and respond to questions. Making a plan and sticking to it is your best defense against this running clock. In oncology, this includes detailed preparation around the mechanism of action, management of side effects, and specific trial design aspects such as inclusion/exclusion criteria and the use of biomarkers.
- Practice Until You Can’t Get It Wrong: The full quote, attributed to best-selling author John Flanagan, is, “don’t practice until you get it right. Practice until you can’t get it wrong.” There is no good reason to have an unforced error in the scripted presentation. And there is no script for Q&A, so respondents need to be practiced in working with the team to compose and deliver flawless responses to questions from Advisory Committee members. Oncology-specific practice should include mock sessions with questions focused on tumor heterogeneity, comparative effectiveness, and patient-reported outcomes.
- Engage the Right Partners: Leveraging experts who understand the FDA’s expectations and have direct experience with Ad Comm meetings can be invaluable. These experts provide guidance on meeting strategies and refine your approach through mock committee sessions. For oncology Ad Comm meetings, it’s particularly important to work with partners who have a deep understanding of cancer biology, clinical trial design in oncology, and the regulatory landscape specific to cancer treatments. They can help anticipate questions related to endpoints, biomarkers, patient selection and post-marketing commitments that are unique to oncology products. Engaging these partners early can ensure that your preparation is aligned with the specific nuances and challenges of oncology drug approval, enhancing the likelihood of a favorable outcome.
While these recommendations remain consistent across various indications and therapeutic areas, it is crucial to include insights specific to the Oncology Product Advisory Committee (OPAC) when discussing oncology-related assets and FDA communications approval. Wael Herb, MD, Vice President of Medical Management in Oncology and Hematology, provides OPAC-specific suggestions to help oncology asset teams prepare for their Ad Comm meetings.
Preparing for ODAC: Recommendations for Oncology Teams
- Focus on Meaningful Endpoint Selections: Endpoints such as overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and minimal residual disease (MRD) are being increasingly recognized as a valuable surrogate endpoints, particularly in hematologic malignancies, due to its ability to predict long-term outcomes.
- Understand Biomarkers and Companion Diagnostics: If your oncology drug relies on biomarkers or requires a companion diagnostic, be prepared to discuss the validation and utility of these tests extensively. Companion diagnostics provide essential information for the safe and effective use of targeted therapies by identifying patients most likely to benefit from a particular treatment, those at increased risk for serious side effects, or by monitoring treatment response to adjust therapy accordingly.
- Clearly Define Patient Population and Inclusion Criteria: Addressing how these choices impact the generalizability of your results and their relevance to the broader patient population,” stresses Dr. Harb. “It is crucial to ensure that the drug can benefit a wide range of patients beyond the clinical trial setting. Include efforts to ensure patient diversity and inclusion in your trials, representing various demographics such as age, gender, ethnicity and socioeconomic status.” Diverse patient populations help to understand the drug's effectiveness across different groups and identify any variations in response or adverse effects, ultimately leading to more comprehensive and equitable healthcare outcomes.
- Plan for Safety Profile and Management of Adverse Events: Oncology treatments often come with significant adverse events. Have a robust plan for discussing how these are managed in clinical practice and what measures are in place to mitigate risks. Highlight any innovative approaches to monitoring and managing toxicity that could improve patient safety. The FDA's Project Optimus is an initiative to reform dose optimization and dose selection in oncology drug development. It emphasizes the need for selecting doses that maximize efficacy while minimizing toxicity, moving away from the traditional maximum tolerated dose (MTD) approach.
- Make Note of Comparative Effectiveness: Be prepared to discuss how your drug compares to existing treatments, highlighting any advantages in efficacy, safety, or quality of life. Comparative effectiveness data, including real-world evidence (RWE), can be compelling in demonstrating the superiority or added value of your drug over current standards of care. Recent examples, like the FDA ODAC vote in favor of imetelstat for transfusion-dependent anemia in patients with myelodysplastic syndrome (MDS) underscore the importance of robust comparative data in regulatory decision-making.
\
By integrating these oncology-specific insights, your preparation for FDA Ad Comm meetings can be more targeted and effective. This ensures that you address the unique challenges and expectations of the oncology review process, ultimately enhancing the likelihood of a successful outcome.
Are you looking to enhance your readiness for FDA Ad Comm meetings? Our experts at Syneos Health can offer guidance and strategic support, drawing on decades of experience in drug development and commercialization.
Contributors
John West | Managing Director, Consulting
Wael Harb, MD | Vice President, Oncology & Hematology Clinical Solutions
Related Content
Looking for exclusive insight?
