FDA Grants Approval to Daraxonrasib Pill for Pancreatic Cancer Treatment
核心洞察
The FDA has approved daraxonrasib, marketed as Rasonque (搜索), an oral once-daily therapy for metastatic pancreatic cancer (搜索), based on review of a 500-adult trial.
Patients receiving daraxonrasib lived a median of 13.2 months versus 6.7 months on standard chemotherapy, roughly doubling survival in the post-chemotherapy setting.
Daraxonrasib blocks an overactive protein that drives tumor growth, and investigators say it is the first oral targeted pill for pancreatic cancer (搜索), with earlier-line studies ongoing.
The FDA has approved daraxonrasib, an oral once-daily therapy marketed as Rasonque (搜索), for metastatic pancreatic cancer (搜索). The agency reviewed a trial of 500 adults in which patients on daraxonrasib lived a median of 13.2 months compared with 6.7 months on standard chemotherapy. The most common side effects reported by the FDA are rash, nausea and abdominal pain, and production is expected to ramp up quickly following approval.
Jonathan Mizrahi, a gastrointestinal medical oncologist at Ochsner MD Anderson Cancer Center (搜索), said daraxonrasib blocks an overactive protein that fuels tumor growth, and that patients who took it after chemotherapy lived about twice as long as those on standard chemotherapy alone. He noted that no oral targeted pill had previously been available for pancreatic cancer (搜索) and that the survival doubling in this setting had not been seen before. The drug is still being studied for earlier lines of therapy.
Mizrahi said 80 to 85 percent of patients are diagnosed too late for surgery, and that symptoms are often vague, including jaundice, yellow eyes and dark urine when the tumor blocks the bile duct. One patient, a retired operating room nurse diagnosed in November, began daraxonrasib in June after chemotherapy and reported no significant adverse reactions.
Source: fox8live.com