Blog: Engaging Innovation

Grace Collins | July 18, 2025

Stakeholder Connect | Insights from the July 17, 2025 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

What was the committee asked to consider?  On July 17, 2025, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to vote on whether the overall benefit-risk profile of two new combination regimens (belantamab mafodotin + bortezomib + dexamethasone [BVd] and  belantamab mafodotin + pomalidomide + dexamethasone [BPd]) for treatment…

Read More

Grace Collins | July 12, 2025

Data Driven Insights | PDUFA at a Glance – Enabling Innovation and Timely Access to New Treatments

As FDA and stakeholders begin preparations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), Friends of Cancer Research’s new Data Driven-Insight provides a high-level overview of the program’s history, impact, and upcoming priorities. This primer provides essential context as public discussions begin around PDUFA VIII. It also highlights how user fee programs…

Read More

May 23, 2025

Meeting Recap | Unlocking Next-Generation Therapies Meeting Recap: Sharing Next Steps and Opportunities with Advocates

On May 22, Friends of Cancer Research (Friends) hosted a public webinar exploring next steps for supporting sustainable development and manufacturing models that can expand patient access to genetically modified cell-based therapies. The webinar, "Unlocking Next-Generation Therapies Meeting Recap: Sharing Next Steps and Opportunities with Advocates," revisited policy discussions from the May 9th public meeting, and proposals from the collaborative white paper developed with the Parker Institute for Cancer Immunotherapy (PICI).

Read More

Karina Bhavsar and Grace Collins | May 19, 2025

Data-Driven Insights | 30+ Years of Accelerated Approval: Trends, Timelines, and Impact

Introduction and Background  The Accelerated Approval (AA) program is a drug development pathway that was established to expedite the delivery of promising treatments to patients, primarily for serious and life-threatening conditions. AA is granted based on surrogate endpoints, such as tumor size reduction in cancer patients, that are reasonably likely to predict clinical benefit. These…

Read More

May 13, 2025

Meeting Recap | Unlocking Next-Generation Therapies

On May 9th, Friends of Cancer Research (Friends), in collaboration with Parker Institute for Cancer Immunotherapy (PICI), hosted a public meeting, “Unlocking Next Generation Therapies: Exploring Innovative Development and Manufacturing Models for Cell Therapies.” This meeting came at a critical inflection point, as the scientific potential of engineered cell-based therapies continue to advance and bring hope for patients. However, regulatory frameworks, manufacturing models, and access mechanisms have not fully evolved to support timely and equitable delivery— particularly for patients with rare cancers and other complex diseases. 

Read More

May 6, 2025

Project Pulse | ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials | CCR

Friends’ recent circulating tumor DNA (ctDNA) study examined 8 clinical trials including 940 patients with advanced non-small cell lung cancer (aNSCLC) treated with tyrosine kinase inhibitors (TKI) to assess whether changes in ctDNA levels could serve as an early indicator of overall survival (OS) and progression-free survival (PFS). The study investigated the association between ctDNA…

Read More

February 24, 2025

Meeting Recap | Advancing the Future of Diagnostics and Regulatory Innovations Meeting Recap: Sharing Next Steps and Opportunities with Advocates

On February 19, Friends of Cancer Research (Friends) hosted a public webinar examining the role of advocacy in advancing AI-enabled diagnostics tools and companion diagnostic (CDx) tests for rare biomarkers. Titled "Advancing the Future of Diagnostics and Regulatory Innovations Meeting Recap: Sharing Next Steps and Opportunities with Advocates," the webinar built upon discussions from the “Advancing the Future of Diagnostics and Regulatory Innovations” public meeting held on February 4...

Read More

Bhaavna Yalavarthi and Grace Collins | February 6, 2025

Data-Driven Insights | 20 Years of FDA Leadership in Novel Cancer Drug Approvals

In 2011, Friends published a study in Health Affairs that challenged the prevailing narrative of the time, which suggested that the U.S. Food and Drug Administration (FDA) was slower and less efficient than other regulatory authorities, such as the European Medicines Agency (EMA). This study provided evidence to the contrary, demonstrating that the FDA approved…

Read More

February 5, 2025

Meeting Recap | Advancing the Future of Diagnostics and Regulatory Innovations

On February 4th, Friends of Cancer Research (Friends) hosted a public meeting, “Advancing the Future of Diagnostics and Regulatory Innovations,” emphasizing the dual objectives of ensuring patient safety while fostering an environment conducive to innovation—a balance that is becoming increasingly critical in an era marked by rapid technological advancements.

Read More

January 13, 2025

Project Pulse | Insights from the Digital PATH Project: HER2 Biomarker Variability Across Artificial Intelligence Models | SABCS

Friends' recent research on homologous recombination deficiency (HRD) involved a comparative analysis of 20 independent HRD assays, assessing both an In Silico (n=348; TCGA database) and a Clinical dataset (n=90; nucleic acids from freshly extracted archival ovarian cancer tumor samples). The assays measured a variety of outputs to define DNA damage repair dysfunction and identify patients with high-grade serous ovarian carcinoma (HGSOC) who had HRD. This is important because patients with HRD may benefit from DNA damage repair inhibitor treatments like Poly ADP-ribose Polymerase Inhibitors (PARPi).

Read More