We’re excited to share more updates from a busy summer at Friends and highlight what’s to come this fall, including upcoming events, advocate perspectives, and research and policy news impacting cancer research.
Here’s what you can read more about in this newsletter:
- What’s Happening at Friends?: Radiopharmaceutical therapies (RPTs) selectively target and deliver radiation to cancer cells while limiting exposure to surrounding healthy tissues, providing a highly targeted treatment option. Read about the unique dosing considerations for these therapies and catch up on Friends’ recent RPT webinar.
- Advocate Spotlight: Read the Advocate Insights blog written by Friends’ Advisory Advocate, Donna Short.
- Mark Your Calendars: Register for the Friends Annual Meeting and Advocates Webinar, and an upcoming external event.
- Data-Driven Insights: Insights on how fast clinical trials start up in the U.S. compared to global trials and what this means for U.S. innovation and the clinical trial ecosystem.
- In Case You Missed It: Catch up on discussions during the latest FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meeting and other regulatory policy news.
What's Happening at Friends?
Optimizing Dosing for Radiopharmaceutical Therapies Webinar
Radiopharmaceutical therapies (RPTs) deliver cancer-killing radiation directly to tumors, but important questions remain about how to optimize their dosing. Friends’ webinar on September 15th brought together clinicians, physicists, and industry experts to discuss how the field can determine safe and effective doses.
Current Challenges
Developers currently borrow safety limits from older external-beam radiation therapy (EBRT), but panelists agreed those limits may not be appropriate for RPTs. RPTs have unique characteristics that can complicate application of traditional dosing approaches, creating a need for tailored approaches to support safe and effective dosing.
One key challenge is that how much radioactive drug is administered (activity) doesn’t consistently predict how much radiation a tumor or organ absorbs (absorbed dose). This relationship varies by drug, patient, and organ, and some toxicities may emerge only after longer follow-up, making early-escalation decisions particularly challenging. Panelists agreed using dose thresholds as hard limits can limit exploration of an optimal dosage.
Opportunities
Careful dosing to minimize toxicities is critical; however, panelists stressed that both undertreatment and overtreatment can negatively affect patients with advanced cancer. In some cases, treatment-related toxicities may be considered acceptable in the context of life-threatening disease, provided patients understand the risks and give informed consent.
Throughout the webinar, panelists emphasized the importance of evidence-driven decision-making. Some prior treatment exclusions, for instance, may not be supported by strong evidence. Patients previously treated with radiation are already safely receiving sequential RPTs in trials, particularly when they have no remaining options.
Why It’s Important for Patients
Unresolved dosing questions directly affect patient safety and access: overly conservative thresholds risk excluding eligible patients or under-dosing them out of caution, potentially reducing efficacy and slowing or preventing development of promising therapies. Rigid trial criteria can exclude patients with no remaining treatment options, even when evidence doesn’t support their exclusion. On the other hand, dosing decisions may lead to patient exposure to greater harm if the dose given, timing between treatments, or total number of cycles is not supported by adequate evidence and safety monitoring. Getting dosing right and basing decisions on shared evidence rather than borrowed assumptions can help ensure patients receive appropriately optimized treatment.
Advocate Spotlight
Donna Short is the Program Director of Advocates for Collaborative Education and a Friends Advisory Advocate. She has over three decades of experience in oncology in a variety of roles. She currently works as a consultant focused on the triangulation between researchers, patients, and pharma companies. She resides in Connecticut with her delightful foster pet failure.
In our latest Advocate Insights blog, Donna wrote about the risks and possibilities of AI and how advocates can help ensure responsible integration of these tools in oncology. Read more here.
Mark Your Calendars
Please register for our upcoming events using the links below.
⬇️ = Reduced Advocate Registration | 🟩 = Free | 🔷 = Friends Event
| 🟩🔷 November 10, 2026 | Friends of Cancer Research Annual Meeting 2026 |
| 🟩🔷 November 17, 2026 | Advocates Webinar: Annual Meeting 2026 |
| ⬇️ December 8-11, 2026 | San Antonio Breast Cancer Symposium |
Data-Driven Insights
In 2025, 80% of patients in pivotal trials supporting novel cancer drug approvals by the FDA were enrolled outside of the U.S. U.S. involvement and leadership in global innovation are critical to ensure U.S. patients have access to novel therapies and that available evidence is applicable to U.S. populations.
In order to maintain U.S. leadership and innovation, we need a trial ecosystem that supports efficient study conduct. We looked at how long U.S. trials take to start up compared to other global regions to better understand where the U.S. excels and where there might be room for improvement.
Our latest Data-Driven Insights Blog shares more insights from a recent Friends survey of pharmaceutical companies examining how fast U.S. clinical trials start compared to those outside of the U.S.
In Case You Missed It
Operation TrialBlazer Stakeholder Connect Blog
What: The U.S. Department of Health and Human Services (HHS) launched a new department-wide initiative called Operation TrialBlazer to “strengthen U.S. leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world“. Our recent Stakeholder Connect blog highlights a series of recent FDA guidance documents and initiatives that will help advance this mission by establishing major efforts to accelerate the initiation of early-stage, first-in-human (FIH) clinical trials and late-stage clinical development.
Why it matters: Operation TrialBlazer and these related regulatory initiatives provide important opportunities and tools to accelerate and streamline drug development. These efforts align with Friends’ mission of powering advancements in science and policy that speed life-changing treatments to patients.
Read more about these initiatives in our recent Stakeholder Connect blog here.
July 30th Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) Meeting
What: On July 30th, the FDA’s CTGTAC considered whether intratumoral injection of the novel oncolytic viral therapy, vusolimogene oderparepvec-wtpg, in combination with nivolumab was appropriate for patients with advanced, anti-PD-1-refractory melanoma. The panel debated whether efficacy data from the single-arm IGNYTE trial reliably demonstrated systemic antitumor activity and meaningful benefit.
Why it matters: The discussion reinforced ongoing questions about how existing response criteria (i.e., RECIST v1.1) and regulatory frameworks apply to intratumoral and other novel local therapies, how sponsors can adequately demonstrate contribution of each therapy to a combination, and the extent to which flexibility can be applied in areas of high unmet need. The committee ultimately voted 10–3 that the regimen was clinically meaningful, which factored into the FDA’s decision to grant accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev) in combination with nivolumab on August 6, 2026.
Read our coverage of the meeting in our Stakeholder Connect blog here.
Resources
ProgressforPatients.org and ProgresoparaPacientes.org
Interested in learning more about drug development and how the FDA functions?
ProgressforPatients.org and ProgresoparaPacientes.org are online advocacy education programs and communities working to help patients, advocates, and caregivers acquire the necessary tools to effectively communicate with drug researchers, drug developers, and regulators.