US health authorities have approved a new drug that doubles the survival time for pancreatic cancer patients.
This comes after a clinical trial showed that the drug can extend average survival by about double compared to chemotherapy alone.
The U.S. Food and Drug Administration (FDA) announced on Wednesday its approval of the drug "daraxonrasib," which targets a gene mutation known as "KRAS" that is linked to about 90% of pancreatic cancer cases.
The drug was approved for treating patients with metastatic pancreatic cancer, meaning cancer that has spread to other parts of the body, after they have undergone chemotherapy. Patients take two tablets of the drug daily.
A clinical trial involving nearly 500 patients with metastatic pancreatic cancer showed that median survival was 13.2 months for those who received daraxonracib, compared to 6.7 months for those who received standard chemotherapy.
Thus, the drug added an average of six months to the lives of patients participating in the trial, with some living for years after starting treatment. The group that received the drug also experienced fewer severe side effects compared to the group that received chemotherapy, the most prominent of which were skin rash, diarrhea, fatigue, and nausea.
Daraxonraceb works by targeting the KRAS protein, mutations of which play a key role in the growth and spread of many pancreatic cancer cells.
The drug aims to disable this protein, thereby limiting the signals that help cancer cells grow, divide, and spread. Targeting KRAS is a significant advancement in pancreatic cancer treatment, given that the mutation is associated with approximately 90% of cases.
Dr. Brian Wolpin, who led the clinical trial at the Dana-Farber Cancer Institute in Boston, said during the presentation of the results at the annual meeting of the American Society of Clinical Oncology that the drug could allow doctors to help metastatic pancreatic cancer patients in ways that were not previously available, while improving survival rates and quality of life.
He added: "I have never seen anything like this before in the trials we have conducted on pancreatic cancer."
Pancreatic cancer presents a significant challenge for doctors, not only because of its aggressiveness, but also because it is difficult to detect in its early stages. Its initial symptoms may be subtle and vague, such as back pain, indigestion, unexplained fatigue, and yellowing of the eyes or skin.
Therefore, in many cases, the disease is not discovered until it has spread beyond the pancreas. At this stage, surgery, which is often the only treatment option that can cure some patients, becomes impossible.
According to the American Cancer Society, only 12% of people diagnosed with pancreatic cancer survive five years after diagnosis. The society's data also indicates that approximately 67,000 new cases are diagnosed in the United States each year, with about 52,000 deaths from the disease.
Revolution Medicines will market the drug under the brand name "Rasonque," but has not yet announced its price.
More than 2,000 patients have received the drug for free since May through the FDA's Expanded Access Program.
The company said that patients who currently receive the drug through the expanded access program will later transition to receiving it through their private insurance companies.
Although daraxonrasib is not a definitive cure for pancreatic cancer, the trial results offer patients with metastatic disease a new treatment option at a time when options have remained limited for many years.
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