Pancreatic cancer had a 13% survival rate. Trump’s FDA just changed everything

The Food and Drug Administration’s approval of an important new drug for patients with advanced pancreatic cancer represents not only a groundbreaking scientific and medical development but also a critical step forward in the Trump administration’s efforts to speed the development of innovative treatment options that can make a meaningful difference in the lives of patients and their families.The development and approval of Rasonque (daraxonrasib), which targets the protein that is a key source of tumor growth in the vast majority of patients who have one of the most lethal and aggressive forms of cancer — pancreatic adenocarcinoma — is a sweeping advance for a disease that has few treatment options and a five-year survival rate of just 13%. Building on research conducted over decades, the new drug is the result of a series of recent breakthrough scientific advances and provides an answer to a puzzle that has challenged and frustrated scientists for years: how to attack and block the protein causing the tumor growth.The clinical trial results of the drug were dramatic, showing a doubling of survival compared to chemotherapy, as well as tumor shrinkage. As the Pancreatic Cancer Action Network, a major advocacy organization for pancreatic cancer patients, stated, this will be the new standard of care for this population. And studies are ongoing with this drug and similar drugs in other cancers impacted by the same pathway. But the scientific achievement is just one part of the story explaining why this development is so important. In delivering this new treatment option months ahead of schedule (and just a little over one month after the application was received), the Trump administration and the FDA are fulfilling our promise to work at the speed of science to provide a fast and thorough review that will allow the development and delivery of more cures, more quickly.How were we able to achieve such stunning results so rapidly? Certainly, the expertise, hard work, and diligence of FDA scientists and staff played a key role. But it also involved communication — often and early — with the applicant. Once clinical trial results were shared with the FDA review staff, we worked closely with the company to make its product available under an expanded access protocol while the product was under review.We used every possible means at our disposal for expedited review, including Breakthrough Therapy and Orphan Drug designations, Priority Review, as well as review under the Commissioner’s National Priority Voucher pilot program, which the Trump administration developed to help accelerate the review of therapies that address national public health priorities. By coordinating across the FDA and, where necessary or possible, across the government, and by communicating with sponsors, and by using all available options to incentivize and speed the process, we are able to reduce the time involved and bring important new treatments to patients more quickly.That’s especially important when it involves a disease as devastating and challenging as PDAC. Each year, nearly 70,000 people are diagnosed with PDAC, and almost 53,000 die. The numbers are sad and staggering, even in the broader world of cancer diagnosis and treatment. While the average five-year survival rate for all combined cancers has reached 70%, and more common cancers such as breast and prostate cancer often feature five-year survival rates exceeding 90%, pancreatic cancer has stalled at roughly 13%. Moreover, 80% to 5% of patients receive a diagnosis at a stage where the cancer is inoperable.This disease doesn’t play favorites. Whether you are a man or a woman, rich or poor, you can get it. It causes great trauma not only to patients, but also to their friends, family members, coworkers, and classmates. This new drug is not a cure, but it can offer a longer life for those with the disease, including more time shared with loved ones. And that’s one reason why the FDA is working to approve promising new treatments like this one.PRICE CAPS SOUND GREAT — UNTIL YOU HAVE CANCER AND A TWO-YEAR WAITLISTAdditionally, by providing incentives and initiatives to speed the review process, we spur innovators to develop new products. For example, the company that created this new drug, Revolution Medicine, is a relatively young American oncology biotech company with no other drugs on the market, just promising research. These initiatives are also helping us regain control of supply chains for both new medicines like these and other essential medicines people depend on. Programs like the Priority voucher program address priorities, including bringing innovative therapies to the people, meeting large unmet medical needs, promoting domestic manufacturing, and increasing affordability.The FDA is not just supporting speedy approval, development, and accessibility of innovative new drugs. We’re also promoting innovation and strengthening U.S. companies that develop new drugs. All of this helps ensure a new era of vibrant drug manufacturing here in the United States, including the development of state-of-the-art treatments that hold the promise to help Make America Healthy Again.Kyle Diamantas is the FDA’s acting commissioner of Food and Drugs.