FDA Early Access for Pancreatic Cancer Drug and ARROW Final Data Highlight Oncology Updates
FDA granted early access to a pancreatic cancer drug; final ARROW data for pralsetinib in RET+ NSCLC were published. A Sarah Cannon Research Institute official outlined a tissue-agnostic vision and highlighted new oncology research.
The FDA has granted early access to a promising drug for pancreatic cancer, according to an announcement by the chief of early-phase drug development at the Sarah Cannon Research Institute. The same official also shared final efficacy and safety data from the Phase I/II ARROW study of pralsetinib in advanced RET fusion–positive non-small cell lung cancer, published in the Journal of Clinical Oncology.
"Patients with one of the deadliest cancers have been pleading for an unapproved treatment that may prolong their lives," the official said, adding that data are expected at the upcoming American Society of Clinical Oncology (ASCO) meeting.
The ARROW study, titled "Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion–Positive Non–Small Cell Lung Cancer," was published in ASCO's Journal of Clinical Oncology. The official noted that the first RET-positive patient in the universe was enrolled on the drug.
In a keynote at the Miami Precision Oncology Symposium, the official shared a vision for accelerating tissue-agnostic drug development from today's 10 approvals to 50–100 in the next 25–50 years, "so every patient receives therapy based on molecular identity, not anatomic accident." A perspective expanding on this vision, titled "Rethinking Cancer Drug Development through Tumor-agnostic Precision Medicine," was published in Cancer Discovery.
The official also highlighted a selection of recent papers: a Nature study on the "Spatial distribution of the proteome in the human body and across cancers," which has implications for precision drug target identification, drug repurposing, and prediction of on-target/off-target effects; a Nature paper on "Evidence for improved DNA repair in the long-lived bowhead whale"; a Nature Reviews Cancer comment on "Mutation-centric kinase drug repurposing for rare cancers"; and a Trends in Cancer article on "Beyond one gene, one target: Next-generation precision oncology." Other highlighted papers covered bacterial engineering for cancer therapy, a high-MAPK, low-WNT cell state driving metastatic dissemination in colorectal cancer, targeting the PI3K/AKT/mTOR pathway, targeting claudins in cancer, pharmacologic inhibition of PMS2, and the gut microbiome in resected high-risk melanoma.
Ahead of ASCO 2026, the official said discussions with a colleague at Pfizer covered "new targets, new drugs, new strategies" and that the meeting with the NCI director underscored that "these are the best times in oncology research" as efforts target the "undruggable." A separate post reflected on the decade-long journey of the ROME trial in precision oncology, published in Annals of Oncology.