All articles tagged with #expanded access
In an expanded-access trial of the FDA-approved pancreatic cancer drug daraxonrasib, patients showed median survival roughly doubling from 6.7 to 13.2 months and tumor shrinkage, with a South Portland man reporting improved quality of life.
Charleston-area patients with metastatic pancreatic cancer are receiving daraxonrasib, a KRAS-targeted drug that showed in Phase 3 trials to roughly double median survival (about 13.2 months versus 6.6 with chemotherapy) via an expanded-access program before FDA approval. Terri Truere became the first local patient treated at Roper St. Francis Cancer Center, a development clinicians say could improve targeting of the KRAS mutation and potentially expand surgical options, though the drug carries notable side effects such as mouth sores, sore throat and rash. The rollout offers optimism for pancreatic cancer treatment and for next-generation KRAS therapies.
A Phase 3 trial showed daraxonrasib, a KRAS-targeting therapy for metastatic pancreatic cancer, nearly doubles median survival (about 13.2 months vs 6.6) and is moving into expanded-access programs, with Terri Truere in Charleston among the first patients in the area to receive it ahead of FDA approval. The drug is not yet approved, but more SC sites are preparing to offer it; it carries notable side effects such as mouth sores and rash, and access remains limited. Doctors see promise that KRAS targeting could improve outcomes and potentially expand surgical eligibility in some patients.
Eli Lilly says it will allow more patients to apply for pre-approval access to retatrutide, the unapproved obesity drug, after previously granting access to a single 79‑year‑old patient; the company is reviewing requests from doctors in line with FDA guidance.
Patients with pancreatic cancer are pursuing Revolution Medicines' experimental drug daraxonrasib through expanded-access programs as the company nears potential approval. While there is optimism the treatment could extend lives, demand is surging and production may not keep up, raising concerns about who receives the drug first and how access will be allocated.