All articles tagged with #expanded access program
Revolution Medicines wins FDA approval for Rasonque (daraxonrasib) in metastatic pancreatic cancer, triggering optimism of a historic oncology launch and potential multi‑billion sales, but raising questions about first‑line use, payer coverage, and how quickly patients move from expanded‑access to commercial treatment amid a $39,800 monthly price and a broad label whose criteria for multiagent therapy remain unclear.
Following dramatic RASolute 302 results, physicians nationwide are offering the oral RAS inhibitor daraxonrasib to patients under expanded-access programs before FDA approval. The drug nearly doubled median overall survival in previously treated metastatic pancreatic cancer (6.7 to 13.2 months) and Revolution Medicines has filed for FDA approval. More than 2,000 patients are on EAP, with sites across the U.S.; institutions cover IRB and safety monitoring costs. Huntsman Cancer Institute reported about 50 patients through its EAP; setup takes 2–3 weeks and delivery occurs in about 7–10 days after consent. Side effects include skin toxicity, managed with dermatology input and topical/doxycycline. Trials continue in first-line metastatic pancreatic cancer, post-surgery settings, and second-line RAS-mutant NSCLC.
Illinois and other states are starting to treat metastatic pancreatic cancer patients with the experimental drug daraxonrasib under an FDA-expanded access program ahead of full FDA approval; early clinical data show a median survival of about 13 months with daraxonrasib versus about six months with additional chemotherapy, with doctors calling it a potential game changer. The drug is provided at no cost through Revolution Medicines, and physicians submit requests for each patient as several Illinois hospitals begin offering it.