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FDA Approves Daraxonrasib for Pancreatic Cancer
Confirmed
In Short: The Food and Drug Administration has approved daraxonrasib, a new drug that could significantly improve survival rates for pancreatic cancer patients.
Oncologists are hailing daraxonrasib as a game changer for pancreatic cancer treatment, which is notoriously difficult to manage due to its late-stage detection and high mortality rate.
According to the American Cancer Society, the five-year survival rate for pancreatic cancer is just 13%, making it one of the deadliest forms of cancer.
Daraxonrasib targets a mutation on the KRAS gene, which is present in most pancreatic cancer patients. This mutation causes the gene to remain in an 'on' position, leading to uncontrolled cell growth.
Vincent Chung, a medical oncologist at City of Hope, explained that daraxonrasib essentially disrupts the mutation's ability to fuel tumor growth, offering a new approach to treatment.
In Phase 3 clinical trials, daraxonrasib increased patients' median overall survival time to 13.2 months compared to 6.7 months for those receiving standard chemotherapy.
While currently approved for late-stage patients who have already undergone chemotherapy, ongoing studies are exploring whether daraxonrasib could be effective as a first-line treatment or in combination with chemotherapy.
Dr. Rachna Shroff of the University of Arizona Cancer Center expressed her excitement, saying, 'Having treated pancreatic cancer for 16 years, I actually started crying' when first seeing the study results.
The Pancreatic Cancer Action Network has declared daraxonrasib the new standard of care for patients with previously treated metastatic pancreatic cancer, marking a significant shift in treatment options.
Revolution Medicines, the company behind daraxonrasib, is now focusing on developing drugs that can counteract a cancer's resistance to RAS-targeted therapies, aiming to further improve patient outcomes.
What this adds
Daraxonrasib is the first approved medication in a class of drugs known as RAS(ON) inhibitors, targeting the KRAS gene mutation.
The drug's approval is expected to benefit a large number of patients since around 90% of pancreatic cancer patients have a RAS mutation.
The approval of daraxonrasib marks a significant milestone in pancreatic cancer treatment, offering hope for improved survival and quality of life for patients.
Background
The FDA has approved Eli Lilly's imlunestrant in combination with abemaciclib for certain breast cancer patients.
What's confirmed
- Those taking daraxonrasib lived for a median of 13.2 months compared with 6.7 months for chemotherapy recipients.
What's still developing
- Pancreatic cancer is known to be very hard to treat, largely due to a lack of early detection tests, meaning that by the time the cancer is found, it’s often advanced.
- Beyond extending their lifespan, daraxonrasib was found to improve quality of life for patients in the trial, too.
- While daraxonrasib does come with side effects such as rash that in some cases can be severe, the pill’s side effects are generally “pretty well managed” and not as intense as what some patients experience with chemo, Chung said.
- Daraxonrasib, however, doesn’t cause the same drop in blood counts, and “you’re able to potentially select out a different population of cells that now are more responsive to IV chemotherapy again when you have to go back to it after daraxonrasib,” Chung said.
- Between 65% to 75% of patients with pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, see their disease recur within five years post-treatment, according to a 2023 study.
- “I think this is just the beginning, not just for daraxonrasib, but for the field at large going after RAS as the target,” Borad said.
- "While not curing the cancer, it is a very large step forward," said Dr. Zev Wainberg, of the University of California, Los Angeles, who helped lead the study.
- The drug is called daraxonrasib and it blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases — a target that had eluded treatment for decades.
- He said the drug should become "a new standard of care" for previously treated metastatic pancreatic cancer, adding that researchers also will explore its use earlier in the disease, including to see if tumor shrinkage might let more patients qualify for surgery.
- Pancreatic cancer is among the most deadly forms in large part because it's hard to detect before it starts spreading to other organs.
- So-called KRAS mutations are especially critical in fueling pancreatic cancer.
- The drug will change pancreatic cancer treatment, said Dr. Andrew Coveler of the Fred Hutchinson Cancer Center, who wasn't involved in the research.