Pancreatic cancer drug dalaxone lasib is called a ‘miracle’
Dalaxone lasib has been shown in clinical trials to nearly double survival for patients with metastatic pancreatic cancer.
An experimental drug nearly doubled overall survival rates for pancreatic cancer patients, according to results from a new clinical trial.
The drug daraxone lasib targets the genetic mutation behind most pancreatic cancer diagnoses.
In a randomized phase 3 trial published May 31 in the New England Journal of Medicine, researchers found that patients who received the drug lived a median of 13.2 months, compared with 6.7 months for patients who received chemotherapy.
“Seeing such an effect in a randomized phase 3 trial is extremely encouraging for all patients with advanced pancreatic cancer and represents a paradigm shift in this deadly disease,” Zev Weinberg, Ph.D., professor of medicine and researcher at UCLA Health Johnson Comprehensive Cancer Center and co-senior author of the study, said in a news release.
Dalaxone lasib, described by some as a “miracle drug,” could be a breakthrough in the treatment of one of the deadliest cancers known, driving demand in clinics while awaiting full government approval.
“We are pleased that we may soon be able to help patients with metastatic pancreatic cancer in a way that has not been possible before, improving both survival rates and quality of life,” said Dr. Brian Wolpin, who announced the study results.
Dalaxone lasib was given the green light by the Food and Drug Administration on April 30 to begin an early access program for some patients.
Early access programs have offered a potential avenue for patients with metastatic cancer, but clinics are already struggling to meet demand.
Dr. Daniel King, a medical oncologist at Northwell Health’s Zuckerberg Cancer Center, told Reuters: “The public became aware of the FDA’s announcement and we were flooded with requests from patients.” “Cancer centers are all publishing protocols for providing access and figuring out how to work with their own institutions.”
Pancreatic cancer has the highest mortality rate of any known cancer, with only 3% of people surviving five years after diagnosis if it spreads to distant parts of the body, according to the National Cancer Institute. According to the American Cancer Society, approximately 67,000 people will be diagnosed with pancreatic cancer and 53,000 will die from pancreatic cancer this year in the United States.
Here’s what you need to know about this drug, how it works, and when it will be generally available.
What is Darathon Lasib?
Dalaxone lasib is an experimental pancreatic cancer treatment manufactured by Revolution Medicines. It is a once-daily pill that has been shown to prolong survival for patients with pancreatic cancer that has metastasized or spread to other parts of the body.
How does Daraxone Lasib work?
This drug works by targeting the most common genetic mutation behind pancreatic cancer.
More than 90% of patients diagnosed with cancer have mutations in a gene called KRAS, Dr. Christopher Liu, an oncologist and professor of medicine at the University of Colorado Anschutz School of Medicine, previously told USA TODAY.
By focusing on the genes themselves, the drug could target the mechanisms behind cancer while potentially limiting the side effects associated with more extensive treatments.
“This drug binds to the activation pocket (of the genetic mutation) and stops it from functioning. It’s like having a megaphone and covering it so the sound doesn’t leak out,” Liu said. “This targeted therapy for pancreatic cancer may work more effectively than chemotherapy, meaning it could potentially be a less toxic treatment.”
Is Daraxone Lasib FDA approved? Is it available to the public?
Dalaxone lasib is currently undergoing FDA review for full approval. The agency has already granted Revolution Medicine permission to begin a limited rollout in late April as part of its expanded access program.
The green light allows the drug company to offer the drug free of charge to some patients previously treated for pancreatic cancer that has spread to other parts of the body.
Under the FDA’s new expedited drug review protocol, daraxone lasib could receive full approval as early as one to two months after formal submission, much faster than the typical 10 to 12 months.
Revolution Medicine has not yet filed an application, but said in a phone call in early May that it was “fully committed” to filing, Reuters reported.
Who can get Daraxone Lasib?
Following news of the expanded access program, cancer clinics have been flooded with applications to participate, Reuters reported on May 14. Demand for the drug is already high and is expected to increase in the future, doctors told the press.
This expanded access program was approved by the FDA specifically for patients who have previously been treated for pancreatic cancer that has since spread. To access this, a licensed treating physician must submit a request to Revolution Medicines, where it will be reviewed by an institutional review board. Pharmaceutical companies told Reuters they expect to respond to these requests within two business days of receiving them.
If the company determines that the drug is suitable for the patient, the details will be submitted to the FDA. Patients are then tracked by the hospital’s oversight committee, and any serious side effects or other issues must be reported to both Revolution Medicines and the FDA.
The early-access priority voucher program was touted as a credit to former FDA Commissioner Dr. Marty McCully, who resigned on May 12, but no intentional changes to the program were communicated.
Former senator promotes ‘miracle drug’
Former Republican Sen. Ben Sasse told “60 Minutes” host Scott Perry in April that Darasonelasib was a “miracle drug” that helped him manage pancreatic cancer that had spread to his lungs and liver.
“I have much, much less pain than when I was diagnosed four months ago, and my tumor volume has decreased significantly by 76 percent in the past four months,” Sasse said in an interview. “So maybe you can crank it out and live a year instead of a few months.”
When he was diagnosed in December, doctors initially gave him three to four months to live, but thanks to “providence, prayer and a miracle drug,” he said he now has a longer life expectancy.
Contributors: Ken Alltucker, Saleen Martin, USA TODAY. Reuters
