Friends of Cancer Research

09/26/2025

This year’s Ellen V. Sigal Advocacy Award went to Peter Marks for his steadfast commitment to advancing public health through scientific integrity and regulatory excellence, and the Marlene A. Malek Public Service Award was awarded to Mark McClellan for his exceptional leadership and enduring contributions to public health.

Watch Dr. Marks (https://bit.ly/47XW50n) and Dr. McClellan’s award videos (https://bit.ly/3IFrham) on our YouTube channel.

09/23/2025

Mark Stewart, Vice President, Science Policy, will be speaking at the Hanson Wade’s 15th World Clinical Biomarkers & Companion Diagnostics Summit, presenting findings from Friends of Cancer Research’s Digital PATH project, which evaluated AI-based HER2 scoring tools in breast cancer. He will also join discussions on the role of AI-enabled H&E-based molecular profiling in diagnosis and collaborative strategies to advance precision medicine.

These sessions will focus on how innovative tools and partnerships can build regulatory confidence, accelerate drug–diagnostic development, and ultimately bring new treatments to patients faster.

09/22/2025

New research led by Friends of Cancer Research shows that reductions in circulating tumor DNA (ctDNA) levels after treatment are associated with improved overall survival (OS) in patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy or chemotherapy. The analysis focused on different early ctDNA timepoints and definitions of molecular response (MR).

Read the full publication: http://dx.doi.org/10.1136/jitc-2025-012454.

The aggregate analysis, published in the Journal for ImmunoTherapy of Cancer, analyzed data from four randomized clinical trials involving 918 patients treated with anti-PD(L)1 therapy (with or without chemotherapy) or chemotherapy alone.

In patients receiving immunotherapy, ctDNA reductions at two early timepoints (i.e., up to 7 weeks and 7-13 weeks after treatment initiation) showed significant associations with improved OS across all MR thresholds (i.e., 50% decrease, 90% decrease, and 100% clearance). Among those treated with chemotherapy alone, these associations were more pronounced when assessing the 7–13-week timepoint. The majority of patients had the same category of molecular response at both timepoints.

These findings support a growing body of evidence from Friends’ ctMoniTR Project. With additional studies planned, these findings bring us closer to a reliable early indicator of treatment efficacy, potentially transforming how we evaluate cancer therapies and accelerate drug development timelines.

Thank you to the authors: Hillary Andrews, Nevine Zariffa, Katherine (Katie) Nishimura, Yu (Yulia) Deng, Megan Eisele, Joe Ensor, Carin R. Espenschied, David Fabrizio, Emily Goren, Vincent Haddad, Minetta Liu, Dimple Modi, Achim Moesta, Katie Quinn, Adam Rosenthal, Diana Merino Vega, Wei Zou, Antje Hoering, Mark Stewart, Jeff Allen.

09/19/2025

Thank you to everyone who joined our 29th Annual Cancer Leadership Awards Celebration! It was truly such a fun evening hosting a visionary group of people dedicated to advancing oncology for all patients.

This year’s Ellen V. Sigal Advocacy Award went to Dr. Peter Marks for his steadfast commitment to advancing public health through scientific integrity and regulatory excellence. Dr. Peter Marks is a hematologist and oncologist who served as the Director of the FDA's Center for Biologics Evaluation and Research (CBER) from 2016 to 2025. Dr. Marks has played a critical role in the development and approval of cell and gene therapies that improve the outcomes of people with cancer.

The Marlene A. Malek Public Service Award went to Dr. Mark McClellan for his exceptional leadership and enduring contributions to public health. Dr. McClellan is the Director of the Duke-Margolis Institute for Health Policy and the Robert J. Margolis Professor of Business, Medicine, and Health Policy at Duke University. His work has focused on improving healthcare quality, payment reform, and the development of real-world evidence.

Watch Dr. Marks (https://www.youtube.com/watch?v=5ZmoVliIMjE&t=25s) and Dr. McClellan's (https://www.youtube.com/watch?v=KIHW0agwDDI) award videos on our YouTube.

A special thank you to our sponsors who made the evening possible!

09/17/2025

How can prior knowledge be better leveraged to accelerate the development of cell and gene therapies, while still maintaining safety and quality?

Friends of Cancer Research submitted public comments to tomorrow’s U.S. Food and Drug Administration CBER OTP Public Listening Meeting, Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies.

In our comments, we recommend:
• Frameworks for extrapolating data across related genetically engineered cellular therapies to reduce redundancy while ensuring safety,
• Approaches to scalable and decentralized manufacturing that can expand access to therapies, particularly in rare disease contexts, and
• Opportunities for collaboration among regulators, developers, and stakeholders to support efficient, safe innovation.

These recommendations build on our recent publications and provide actionable strategies to help the FDA and developers streamline the development of cell and gene therapies, reduce redundancy, and advance safe and efficient pathways that ultimately improve patient access.

We appreciate the FDA’s efforts to foster collaboration and dialogue on these issues and look forward to continuing our work together to advance the safe and efficient development of cell and gene therapies.

Read the full comment: https://friendsofcancerresearch.org/publication/public-comments-fda-cber-otp-public-listening-meeting-leveraging-knowledge-for-facilitating-the-development-and-review-of-cell-and-gene-therapies/.

09/16/2025

Research funded by the NIH is the cornerstone of new advances against the toughest diseases we face, and it fuels jobs and economic growth across the United States. Every dollar invested in NIH generates $2.56 in economic activity, contributing nearly $95 billion to the U.S. economy in FY2024 and supporting over 407,000 jobs across nearly every congressional district. Cutting back now would weaken America’s economy, weaken our national security, and cede leadership in medical innovation.

On Thursday, September 18, 2025, a nationwide coalition of nearly 400 medical research advocacy organizations representing millions of Americans will gather on Capitol Hill to thank lawmakers for their longstanding support of NIH and to urge Congress to provide a robust funding increase in Fiscal Year 2026 to safeguard the future of lifesaving medical research.

Take action today: https://rallyformedicalresearch.org/!

09/15/2025

Check out the Q3 2025 edition of the Friends of Cancer Research Advocacy Newsletter!

In this issue, we spotlight:
• ai.RECIST Project – Learn about our new project in tumor response assessments through AI integration.
• Engaging Innovation Blog – Insights from the July 17 ODAC hearing and the latest on PDUFA Reauthorization.
• 2025 Leadership Awards – Celebrate the achievements of our 2025 awardees’ contributions to research and patient advocacy.

Read the latest issue and subscribe to stay ahead of developments shaping cancer research and patient advocacy: https://friendsofcancerresearch.org/blog/quarterly-advocacy-newsletter-q3-2025/.

09/12/2025

How do we fairly evaluate the contribution of each drug’s effect in complex cancer combination trials, without slowing patient access? Friends of Cancer Research submitted comments on U.S. Food and Drug Administration draft guidance to help address this challenge.

Our key recommendations include:
• Recognizing when factorial designs are not scientifically, ethically, or operationally feasible, particularly in small biomarker-defined populations or when monotherapy data already show limited efficacy
• Expanding use of external data, including patient-level real-world evidence—with transparent, pre-specified methods to strengthen credibility and reproducibility
• Providing clearer guidance for different types of combination scenarios, including when adaptive designs, early endpoints, or external data can appropriately support contribution of effect.

We commend the FDA's commitment to addressing the challenges of evaluating the Contribution of Effect in combination therapies and look forward to continued regulatory guidance that helps bring safe, effective treatments to patients faster.

Read our full comment: https://www.regulations.gov/comment/FDA-2025-D-1071-0007.

09/10/2025

Mark Stewart, Vice President, Science Policy, will be a panelist at the U.S. Food and Drug Administration-American Association for Cancer Research (AACR) Workshop: Approach to Novel Oncology Endpoint Development. During the “Evidence Gaps in Endpoint Development: Case Studies in ctDNA” panel discussion, he will share insights from our ctMoniTR project and highlight how standardization, harmonization, and collaboration are essential to advancing novel endpoints like ctDNA. These efforts are key to ensuring reproducible evidence and building the frameworks needed to accelerate safe and effective cancer treatments for patients.

09/04/2025

“I've dedicated my career in developing a cure for cancer, now I'm stepping into the ring to knock out .” Katherine Cheng is lacing up her gloves on October 9th in support of Friends of Cancer Research. Her commitment to cancer research, both professionally and as part of this amazing charity event, are advancing the fight for the cure that we’re all in together.

-Click here to help Katherine reach her $20,000 goal to raise money for critical cancer research: https://haymakersforhope.org/events/boxing/belles-of-the-brawl-2025/fighters/katherine-cheng

“I fight for all the cancer researchers to find a cure, so that no patient will need to suffer any longer. I fight for .”

https://www.youtube.com/shorts/TI_5qogWE80

Come support Katherine Cheng to help KO cancer at the Haymakers for Hope Belles of Brawl - Oct 9 Boston MGM Music Hall 7:30pm. Purchase Tickets Here: " unloc...

09/03/2025

Friends of Cancer Research’s ProgressforPatients.org course is a free, self-paced online educational program designed to empower patients, advocates, and caregivers with the tools to effectively engage with researchers, developers, and regulators.

It is perfect for those ready to get involved in advocacy efforts across pharma, medical organizations, and patient advocacy groups.

Take the course today! https://progressforpatients.org/

09/02/2025

Patients and families are speaking with one voice. 47 leading patient advocacy organizations have urged the House Appropriations Committee to support robust federal funding for medical research in FY26. This investment fuels breakthroughs, from better cancer treatments to diabetes technology, newborn genetic testing, stroke therapies, CAR-T, and AI-driven diagnostics. Cuts would slow lifesaving progress.

Read more and see the coalition letter: https://unitedforcures.org/47-leading-patient-advocacy-organizations-urge-house-appropriators-to-support-robust-federal-funding

47 Leading Patient Advocacy Organizations Urge House Appropriators to Support Robust Federal Funding for Medical Research WASHINGTON (September 2, 2025) – Today, 47 of America’s largest and most influential patient advocacy organizations called on the House Committee on Appropriations to priorit...