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Pink Sheet – US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch

Pink Sheet – US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch

The US Food and Drug Administration quietly unveiled yet another Oncology Center of Excellence “project.” This one, Project Protect, is aimed at providing “consistent advice and review” of safety signals across oncology drug classes.

In what has become a familiar strategy for Director Rick Pazdur, OCE launched Project Protect without fanfare in 2021. OCE first mentioned the program in its recently released 2021 annual report, noting that it has already been used to support 44 drug applications.

The new program establishes “a uniquely structured safety team organized by drug class to provide consistent advice and review of safety signals in the pre- and post-market setting,” OCE says. The new safety team supports both CDER and CBER review teams.

“Project Protect engaged external stakeholders to develop, expand, and customize safety data standards across CBER and CDER to expedite regulatory review and research,” OCE wrote in the report. “It also helped develop new immune-oncology focus groups. Project Protect continues to build a team of safety data analysts and data engineers to assist with safety data analytics and safety regulatory research to further the mission of OCE.”

As part of Project Protect, OCE has developed a “Safety Analysis Generator” (SAG), which OCE describes as a tool that “aids in the efficient review of applications and provides individual data” for oncology-specific applications. The SAG was launched in March 2021.

Project Protect was listed in the OCE annual report as one of six “newly launched or ramped up” projects during 2021. Here are the other programs highlighted:

Project Catalyst

Project Catalyst provides guidance and educational resources primarily to small pharmaceutical companies and academic life science incubators and accelerators to expedite the availability of directed and novel cancer treatments to the public.

In 2021, the project developed a webpage for its educational initiative, Oncology Regulatory Expertise and Early Guidance, which is a self-directed platform providing early-stage oncology companies with product-type advice.

This platform will be updated with additional “bench-to-bedside” chats with regulatory science experts and answers to frequently asked questions. The project welcomes questions regarding oncology drug development plans that are premature for pre-IND submission. Project leads are Oncology Center of Excellence Deputy Director Marc Theoret and Office Oncologic Drugs Associate Director of Translational Sciences Jeff Summers.

Project Confirm

Project Confirm (formerly “Project Accelerate”) was created to increase the transparency of outcomes related to oncology accelerated approvals, including a searchable public database of all AAs since the program started in 1992. The Project Confirm webpage also provides an overview of Accelerated Approval and includes frequently asked questions about the regulatory pathway.  (Also see “From ‘Accelerate’ To ‘Confirm’: US FDA Launches Transparency Program On Cancer Drug Approvals” – Pink Sheet, 28 Oct, 2021.)

New in 2021 (along with the new name) were two publications co-authored by Pazdur and OCE Acting Deputy Director Julia Beaver on OCE’s efforts to address “dangling” or “delinquent” Accelerated Approvals.  (Also see “Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development ‘Wild West’” – Pink Sheet, 15 Dec, 2021.)

Project Optimus

Project Optimus was launched in 2021 as an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Officials delivered the “more is not necessarily better” message at a number of public sessions, including panels at American Association for Cancer Research and Friends of Cancer Research events.  (Also see “Pazdur To Oncology Drug Developers: Step Back, Slow Down – And Find The Right Dose” – Pink Sheet, 13 Aug, 2021.)

Dose optimization also was a key post-marketing requirement of Amgen, Inc.’s Lumakras (sotorasib) approval in non-small cell lung cancer.  (Also see “US FDA Plans To Get Tougher On Oncology Dose Optimization” – Pink Sheet, 16 Jun, 2021.)

Project Equity

Project Equity is an initiative launched on 2021 to ensure that data submitted to FDA for approval of oncology medical products adequately reflects the demographics of patients for whom the products are intended. Project Equity focuses on ethnic and gender minorities. A different program, “Project Silver,” focuses on patients older than 75.  (Also see “US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data” – Pink Sheet, 15 Feb, 2021.)

The Project Equity program lead is Lola Fashoyin-Aje, OCE Associate Director of Science and Policy to Address Disparities.

Project Significant

Project Significant (Statistics in Cancer Trials) promotes collaboration and engagement among diverse stakeholders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies. The program launched in 2020.

OCE holds discussions with the Biopharmaceutical Section of the American Statistical Association and other oncology stakeholders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies. Seven publications summarizing these discussions were published in 2021.

Other Programs

The Oncology Real World Evidence Program, which was launched in 2020, advances the appropriate use of RWE to facilitate patient-centered regulatory decision-making. Staff assess regulatory submissions containing real-world data across oncology review divisions.

The Oncology RWE program is active in another OCE program, Project Post-COVIDity, which advances the understanding of COVID-19’s effects on patients with cancer. Work in 2021 including publications based on research with several data providers.

The Rare Cancers Program leverages OCE’s ongoing initiatives to promote development of safe and effective new drugs and biologics to treat patients with rare cancers. The program was started in 2021 and in February 2022 launched a new webpage.