The U.S. Food and Drug Administration has approved a new pancreatic cancer pill after a large trial showed that it could double survival rates in patients with advanced disease.
The once-daily tablet has been approved for metastatic pancreatic cancer in patients who have already received treatment or cannot undergo combination chemotherapy. The drug works by blocking several forms of the RAS protein, which helps drive tumor growth in many pancreatic cancers.
The treatment is now available in the United States at a price of $39,800 for a 30-day supply. Eligible commercially insured patients may pay as little as $0 with co-pay assistance.
When trial results were announced in April, demand for the drug rose sharply. The FDA later granted early access under its compassionate use programme, allowing patients with serious or life-threatening conditions to receive experimental treatments before full approval.
Some patients who received early access said the treatment helped them avoid the harsh side effects of chemotherapy.
One patient, 88-year-old Barbara Andes of Fullerton, California, said the pill allowed her to resume normal activities and caused far less nausea and fatigue after a year of chemotherapy.
Experts said the approval marks an important advance for patients and families facing metastatic pancreatic cancer, which remains one of the deadliest forms of the disease.
The drug was also among the first therapies accepted under the FDA’s expedited review process, which is designed to shorten approval timelines for treatments addressing major health priorities and unmet medical needs.
Investor confidence had already risen sharply after the trial data, pushing the company’s stock up significantly this year. Analysts said the approval could generate strong U.S. sales in the coming quarters and may eventually become a major treatment option.
Health experts estimate that tens of thousands of people are diagnosed with pancreatic cancer each year in the United States, underlining the need for new and effective treatment options.
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