The Oncology Center of Excellence developed an Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment of the NDA/BLA application, including supplements.
The Assessment Aid is based on the FDA Multidisciplinary Review template. The main objectives of the Assessment Aid are to (1) focus the FDA review on critical thinking (assessment) and (2) increase review efficiency and consistency, and decrease review time spent on administrative tasks such as formatting.
The Assessment Aid provides a generic structure that covers the application’s key points. It is a stand-alone document; i.e., the information and supportive evidence provided should be concise and self-sufficient. Certain sections in the document have been divided into three parts, clearly delineated to emphasize the ownership of each position:
- Data (completed by the applicant);
- The Applicant’s Position (completed by the applicant);
- The FDA’s Assessment (completed by FDA).
The “Data” section should be a concise presentation of the objective results, the data. “The Applicant’s Position” should be the applicant’s interpretation of the data presented. The applicant should use U.S. English throughout their sections. Whenever possible, use FDA’s suggested abbreviations, found in the “Glossary” section of the template, and use only common U.S. abbreviations (e.g. use BID instead of b.d. to refer to twice a day dosing regimens). “The FDA’s Assessment” is the FDA’s analysis of the data presented and the applicant’s position.
The applicant should only include critical information (e.g., total document should be no longer than 100 pages for NME applications or 75 pages for supplemental applications). This text should be annotated with references to the detailed information in the study reports and the relevant dataset in the submission. Promotional language should be avoided.
The FDA encourages inclusion of complementary tables and figures as appropriate. The applicant should provide the names of the datasets used to derive the information presented in the table.
As this is a general template, the applicant only needs to fill in responses to the sections relevant to the current submission. If no new information is provided for certain sections (i.e., there may not be new clinical pharmacology information submitted in certain supplement NDAs), the applicant can state under the main heads of these sections, "No new information is provided in the current submission," and delete all subheads.
The applicant should submit this document in Microsoft Word format. It is the applicant’s responsibility to ensure all their hyperlinks work. Once submitted, the applicant would generally not have the opportunity to revise their portion of the Assessment Aid.
If the applicant participates in the Real-Time Oncology Review (RTOR) program, they may submit the Assessment Aid before or at the time of (supplemental) NDA/BLA submission. The FDA review team, after conducting their scientific evaluation, will add their assessment to the same document. The FDA’s assessment will focus on whether FDA agrees or not with the applicant’s position, and any additional findings and analyses.
An applicant can communicate interest in participating in the Assessment Aid program to the FDA review division by sending a notification of interest to the division Regulatory Project Manager prior to application submission or at the pre-NDA/BLA meeting. Those applicants who do not wish to participate in the Assessment Aid will follow the usual submission process with no impact on review timelines or benefit-risk decisions.
Q1. Can all oncology drug applications use the Assessment Aid? Where can applicants find the Assessment Aid?
Yes, applicants can communicate interest in participating in this program to the corresponding CDER Office of Oncologic Diseases review division. The division will send the template to the applicant during the investigational new drug (IND) stage.
Q2. How is the Assessment Aid different than the currently used FDA Multidisciplinary Review document?
The applicant will complete a template, detailing the applicant’s position. The FDA will then provide their own independent assessment in response to the applicant’s position, using this same template. This will create a more efficient and streamlined review process and reduce the administrative burden on FDA reviewers by permitting them to focus on key results and perform critical analyses that may have been omitted by the applicant. Importantly, the new format leads to a more dynamic review process where key regulatory questions can be answered more thoroughly and effectively.
Q3.: Are there examples of completed Assessment Aids?
Examples of original and supplemental applications are provided below:
- BLA 761137 (enfortumab vedotin-ievx)
- NDA 212526 (alpelisib)
- sNDA 210259/S-6 (acalabrutinib)
- sBLA 208558/S-13 (venetoclax)
- Office of Oncologic Diseases (OOD)
- OOD Divisions and Contact Information
- Information for Sponsors: Submissions to the Office of Oncologic Diseases (OOD)
- Real-Time Oncology Review Pilot Program