An experimental drug targeting a common pancreatic cancer gene mutation is generating high demand at clinics as it nears full FDA approval. Daraxonrasib, developed by Revolution Medicines, was approved for early access on April 30, offering hope to patients with metastatic disease.
Clinical trials show the once-daily tablet extends median survival to 13.2 months, nearly double the 6.7 months for standard chemotherapy, according to data released in April. The drug targets the KRAS gene mutation present in over 90% of pancreatic cancer cases, effectively shutting down the cancer's mechanism with potentially fewer side effects than chemotherapy.
“The public caught wind of the FDA announcement, triggering a deluge of patient requests,” Dr. Daniel King, medical oncologist at Northwell Health, told Reuters. “Cancer centers are figuring out how to engage with their institutions to open protocols.”
Pancreatic cancer remains one of the deadliest cancers: only 3% of patients survive five years after distant metastasis. The American Cancer Society estimates 67,000 new diagnoses and 53,000 deaths in the U.S. this year.
The expanded access program is for patients previously treated for metastatic disease. Licensed physicians must submit requests to Revolution Medicines, with responses expected within two business days, followed by FDA review. Former Senator Ben Sasse described the drug as a “miracle drug,” reporting a 76% reduction in tumor volume and significantly less pain. Full approval could come within one to two months after the company files its formal application.