Oncologists are hailing a recently approved drug as a game changer for pancreatic cancer treatment.<\/p>\n
The FDA on Aug. 26 approved Revolution Medicines\u2019s daraxonrasib, which will be sold under the brand name Rasonque, to treat metastatic pancreatic adenocarcinoma in patients who\u2019ve undergone prior chemotherapy treatment.<\/p>\n
In Phase 3 clinical trials<\/a>, daraxonrasib increased patients\u2019 median overall survival time to 13.2 months compared to 6.7 months for patients taking standard chemotherapy treatment when measured from the time of randomization in the trial.<\/p>\n That kind of success is \u201clike climbing Mount Everest for the first time,\u201d Mitesh Borad, an oncologist and professor of medicine at Mayo Clinic in Arizona, told Healthcare Brew. Borad served as principal investigator for the three Phase 3 trial sites located at the Mayo Clinic\u2019s Minnesota, Arizona, and Florida campuses. He was also a consultant for Revolution Medicines prior to the clinical trial.<\/p>\n The trial was conducted at 59 sites in six countries.<\/p>\n When initial results from the trial were released in April, the drugmaker\u2019s stock shot up 58% in two days from $96.43 to $152.54. Since then, the stock has continued to grow gradually. It reached $208.04 as of Sept. 2.<\/p>\n How it works. 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\u2019s often advanced. It also grows rapidly, Borad said. The five-year survival rate is just 13%, according to the American Cancer Society.<\/p>\n Daraxonrasib, which is taken as a once-daily pill, is the first treatment to target a mutation on the KRAS gene, which is found in most pancreatic cancer patients. Scientists have been trying to target the gene for decades with little success.<\/p>\n The KRAS gene is one of three in the RAS family of genes. KRAS helps regulate cell growth by working as a kind of on-off switch. The mutation seen in pancreatic cancer patients causes the gene to get stuck in the \u201con\u201d position, therefore causing uncontrolled cell growth, according to MD Anderson<\/a>.<\/p>\n Daraxonrasib essentially throws \u201ca wrench in the machine\u201d and stops the mutation from fueling that growth, according to Borad.<\/p>\n The benefits. Beyond extending their lifespan, daraxonrasib was found to improve quality of life for patients in the trial, too.<\/p>\n The IV chemotherapies that have been standard of care for pancreatic cancer tend to come with significant side effects, according to Vincent Chung, a medical oncologist specializing in pancreatic and gastrointestinal cancers at City of Hope, a comprehensive cancer center in Los Angeles. Chung served as principal investigator for the Phase 3 trial site at City of Hope.<\/p>\n While daraxonrasib does come with side effects such as rash that in some cases can be severe, the pill\u2019s side effects are generally \u201cpretty well managed\u201d and not as intense as what some patients experience with chemo, Chung said.<\/p>\n Daraxonrasib may also allow patients to stay on optimal doses of chemo for their disease for longer periods rather than having to lower their dosage to mitigate hematological side effects, Chung added.<\/p>\n Navigate the healthcare industry<\/p>\n Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.<\/p>\n In traditional pancreatic cancer treatment, patients go from one kind of IV chemo to another. Because the treatments are given sequentially, the side effects tend to be cumulative, according to Chung. Those side effects can sometimes make a patient\u2019s blood counts drop so low their oncologist has to reduce the chemo dosage\u2014or stop it altogether\u2014and wait for the blood counts to recover before they can continue treatment.<\/p>\n Daraxonrasib, however, doesn\u2019t cause the same drop in blood counts, and \u201cyou\u2019re 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,\u201d Chung said.<\/p>\n Future potential. While the treatment is currently only authorized for late-stage patients who\u2019ve already undergone chemotherapy, studies are ongoing to determine whether daraxonrasib would be effective prior to or in combination with chemo, Borad said.<\/p>\n It\u2019s also being studied to see if it could prevent recurrence in patients without metastatic disease who\u2019ve undergone surgery and chemo. 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<\/a>.<\/p>\n \u201cI think this is just the beginning, not just for daraxonrasib, but for the field at large going after RAS as the target,\u201d Borad said.<\/p>\n Scientists are also studying whether daraxonrasib could work for other cancers that involve RAS mutations, such as lung, biliary tract, uterine, and some types of ovarian cancers, he added.<\/p>\n It\u2019s unclear how many patients are currently eligible for daraxonrasib under the FDA\u2019s approval, but \u201cit will be a large number\u201d since around 90% of pancreatic cancer patients have a RAS mutation, Chung said. Roughly 67,530 people in the US will be diagnosed with pancreatic cancer this year, according to the American Cancer Society.<\/p>\n Anthony Mancini, Revolution Medicines\u2019s chief global commercialization officer, said in a statement emailed to Healthcare Brew that the company\u2019s \u201cmanufacturing scale is sufficient to support US launch needs.\u201d<\/p>\n Access to the treatment may be a challenge, as daraxonrasib comes with a monthly list price of $39,800<\/a> before insurance, according to an SEC filing<\/a>. It\u2019s so far unclear how much insurance will cover. Comparatively, folfirinox, a combination chemotherapy regimen commonly used to treat metastatic pancreatic cancer, was estimated to have a monthly acquisition cost of about $5,501 per month, per a 2024 analysis<\/a> presented at the American Society of Clinical Oncology\u2019s annual meeting.<\/p>\n Mancini said the price \u201creflects its differentiation and the meaningful benefit it provides for patients,\u201d and that Revolution has a \u201ccomprehensive patient support program\u201d to help patients gain access.<\/p>\n \u201cIt\u2019s just an exciting time,\u201d Chung said. \u201cIt\u2019s a wonderful time in terms of being able to do research in this field.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Oncologists are hailing a recently approved drug as a game changer for pancreatic cancer treatment. 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