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The ongoing developments in the approval outcomes and breakthroughs of specialized therapies by the U.S. Food and Drug Administration, including resubmissions leading to approvals and the introduction of new treatments for specific medical conditions.
NPR's A Martinez spoke with STAT science and health reporter Adam Feuerstein about the FDA's approval of a new drug to treat pancreatic cancer, an interview the public broadcaster framed as covering a breakthrough treatment for one of the deadliest forms of cancer. The conversation focused on daraxonrasib, the first therapy approved to directly target mutated KRAS proteins that fuel the majority of pancreatic tumors.
The U.S. Food and Drug Administration on Wednesday granted expedited approval to daraxonrasib, a daily pill that targets a mutated protein driving more than 90% of pancreatic cancers, the agency said. The drug, developed by Revolution Medicines and to be sold as Rasonque, is the first treatment to overcome an obstacle that had long made the cancer driver "undruggable."
The U.S. Food and Drug Administration on Wednesday granted expedited approval to daraxonrasib, a daily pill from Revolution Medicines that will be sold under the brand name Rasonque for the most common form of pancreatic cancer. The first-of-a-kind drug blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases, an approach that previously eluded drugmakers for decades.
Replimune Group said Thursday that the U.S. Food and Drug Administration approved Tudriqev, its therapy for advanced melanoma, after two previous rejections. The accelerated approval makes Tudriqev the second FDA-approved option for melanoma patients who have stopped responding to immunotherapy drugs, after Iovance Biotherapeutics' Amtagvi.
The U.S. Food and Drug Administration on Wednesday approved Orzeyful (oveporexton), the first drug to treat the full range of narcolepsy type 1 symptoms in adults. The agency granted the approval to Takeda Pharmaceuticals America.