The Food and Drug Administration has revealed that some patients suffering from pancreatic cancer will be authorized for early use of the highly-promising treatment drug daraxonrasib.
The announcement was immediately seen as a highly significant development for those following the dramatic and encouraging trial results of daraxonrasib, which have reported greatly prolonged survival rates.
Friday’s FDA move will create a pathway for patients who have previously been treated for the disease to gain access to daraxonrasib, which is taken in pill form three times a day, even before it is officially approved for use.
“Today, the U.S. Food and Drug Administration is announcing that it issued a ‘safe to proceed’ letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib,” an FDA statement read.
“The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.”
FDA commissioner Dr. Marty Makary insisted that granting the request within two days of receiving it proved the organization’s commitment to allowing early access to therapies for serious and life-threatening conditions.
“Having taken care of many patients with metastatic cancer, I am hopefully that today’s action will improve the lives of patients suffering from this disease,” Makary said.
California-based Revolution Medicines, the drug’s developer, pushed for expanded access and revealed it receives a huge number of requests from patients and their families around the world.
“This authorization represents a critical step in the process of opening an EAP,” a Revolution Medicines statement read. “Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States.”
Both the FDA and Revolution Medicines clarified that permission requests for expanded access must come from a licensed physician in the U.S.
In April, the New York Times reported on daraxonrasib’s impressive results, which were discussed at a cancer conference in San Diego.
The NYT said pancreatic cancer has “one of the grimmest prognoses in oncology,” with many patients dying within months of diagnosis.” According to cancer.org it kills more than 50,000 Americans a year, accounting for roughly 8 percent of cancer deaths in the United States.
Five year survival rates hover as low as 3 percent.
The Trump administration has fast-tracked review a review of daraxonrasib and approval may come later this year. Meanwhile, expanded access is intended for those suffering the most severely from the disease and with all other options exhausted.
Revolution’s eye-catching figures in April touted “unprecedented overall survival benefit.” Patients receiving the drug survived for more than 13 months, nearly double compared to those receiving chemotherapy, the company said.
Daraxonrasib seeks to target KRAS, a mutation that propagates growth in nearly all forms of pancreatic cancer. Usewr have reported side effects such as rashes, nausea and fatigue.
Among the drug’s trialists is Ben Sasse, a former Nebraska senator. Sasse told the NYT last year that the drug has caused his tumors to shrink and enabled him to reduce his usage of pain medicine.