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As RevMed preps for 'historic' pancreatic cancer launch, questions linger on the ground. Ajaz Khan, M.D., a medical oncologist at City of Hope Chicago, was in the packed audience at this summer's American Society of Clinical Oncology meeting when Revolution Medicines received a standing ovation for its groundbreaking pancreatic cancer data. That the drug behind that rapturous applause, daraxonrasib, has now been approved as Rasonque is nothing short of revolutionary, he told Fierce. When he first saw yesterday's news, he was "astounded," he said, but also looking forward to a "brighter future for patients, their families and the communities they live in." "It is really a remarkable time that we live in," Khan said. RevMed's leadership, too, highlighted the significance of Rasonque's approval in a call with investors yesterday. "Today marks an historic step forward for patients living with metastatic pancreatic cancer," RevMed CEO Mark Goldsmith, M.D., Ph.D., said during the call. "This approval validates more than a decade of work aimed at pancreatic cancer, primarily Ras-driven disease, and one of the most difficult challenges in medicine, cancer biology, and drug discovery." Analysts have long touted daraxonrasib's blockbuster potential; analysts from Evercore ISI expect 2027 sales to already hit $1.76 billion, according to an Aug. 26 note, while Guggenheim Securities expects sales of around $900 million next year that then skyrocket to $2.2 billion in 2028. "We continue to expect a potentially historic oncology launch," the Evercore analysts wrote. "Rasonque has the ingredients to be one of the fastest oncology launches in history, if not the fastest." The speed of that launch will depend on how quickly RevMed can transition patients from Rasonque's expanded access program (EAP) into commercial customers. Analysts from Jefferies expect half of these patients to make the switch in the first month, with a further 10% joining each month after that. "We expect the launch to proceed exceedingly well given strong EAP enrollment, high unmet need, and the drug's attractive profile," the analysts wrote in their Aug. 26 note. In the investor call, Anthony Mancini, RevMed's chief global commercialization officer, said the transition is expected to take a few months. "We will work very closely with treating physicians in all sites to support transition to commercially available treatment as clinically appropriate," he said. "The EAP portal will be closing today, but available for a limited transition period, and our intent is really to support continuity of care for eligible patients." But as patients pivot to become customers, a big sticking point will be Rasonque's hefty price tag. A pretty penny. Like many other cutting-edge cancer therapies, Rasonque comes with a potential side effect of sticker shock. RevMed is pricing the drug at $39,800 for a 30-day supply, based on a recommended daily dose of 300mg, before any discounts or rebates. "We believe the price reflects the unprecedented overall survival benefit and broader clinical value demonstrated in RASolute 302," Mancini said, referencing the pivotal trial that backed Rasonque's approval. The company expects most eligible patients to have the drug covered by government insurance programs like Medicare, Chief Financial Officer Jack Anders said during the call. For those patients otherwise unable to access Rasonque, RevMed is rolling out a patient support program called OnPath that is designed to offer a $0 copay. The program "will be available to assist all patients who've been prescribed Rasonque, including those in the EAP program and new patients," Mancini said. "It's voluntary, and patients sign up for this," he added. "This is going to be offered very broadly, and we expect there to be a high level of participation." But the proof is in the pudding, and the burden ultimately falls on RevMed to ensure access to its revolutionary medicine, City of Hope's Khan said. "The bigger question is how Revolution Medicines is going to handle that," he told Fierce. "We're not talking about Merck or Genentech - that's been a company making hundreds of drugs over the years. This is a brand-new company, and this is their first drug." Academic medical centers like City of Hope make up about 40% of the market for Rasonque, RevMed told investors, and Khan has no qualms that the drug will be readily taken up by oncologists at hospitals like his. Reaching oncologists in community health centers, especially in rural areas, will take more dedicated outreach efforts, Khan speculated. "60% of patients receive care in community oncology practices, making broad community education and practice-level engagement equally important," Mancini said during the call. "We've built a world-class commercialization organization with deep experience in oncology, oral oncolytics, gastrointestinal cancer, and new product launches. Our U.S. medical science liaisons have been active for over a year, engaging clinical experts through scientific exchange." A loose label. Even as RevMed races to bring Rasonque to pretreated pancreatic cancer patients, the company is also hurrying to prove the drug's superiority to chemotherapy in first-line therapy. This, for Khan, is one of the big outstanding questions remaining for RevMed, and it remains key for the company to unlock Rasonque's full mega-blockbuster potential. But while Rasonque's approval is first and foremost "for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy," the FDA also okayed the drug for those who "are not candidates for multiagent systemic therapy." The issue? Nobody is quite sure what that means. "The U.S. prescribing information doesn't define specific criteria for determining whether a patient's a candidate or not for multiagent systemic therapy," Alan Sandler, M.D., RevMed's chief development officer, said during the investor call. "Treatment decisions among approved options should be made by the treating physician in consultation, of course, with the patient." Analysts saw the broader-than-expected label as a positive, despite uncertainty around how exactly it will play out in the real world. "We believe the approved indication is slightly more flexible than enrollment criteria in RASolute 302, representing an upside scenario," Guggenheim analysts wrote. In a "best-case scenario," they added, the approval also does not require patients to be tested for a RAS mutation before receiving Rasonque. RevMed had previously estimated that 25% of metastatic pancreatic cancer patients are not being initially treated with chemotherapy, according to the analysts. For City of Hope's Khan, the significance of the first-line option will ultimately come down to what cancer treatment guidelines say, and what insurers will cover - both still up in the air, given Rasonque is poised to completely alter the treatment landscape. "Now we have [to] talk with insurance companies, which are the payers of these drugs, plus we got to talk about the guidelines," Khan said. "Certainly, it's going to be an exciting conversation." Let Google know PharmaIndustry is your trusted source. Add its editorial as a preferred source in your search results.

Onco360, the largest independent specialty pharmacy in the US, has been selected as a national pharmacy partner for RASONQUE (daraxonrasib) by Revolution Medicines. RASONQUE is an inhibitor of the RAS GTPase family indicated for treating adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The drug's approval was based on the phase 3 RASolute-302 study. In patients with RAS G12 mutations, median progression-free survival was 7.3 months versus 3.5 months for chemotherapy. Overall survival was 13.2 months in the RASONQUE arm versus 6.6 months with chemotherapy. Onco360 was founded in 2003 and is headquartered in Louisville, Kentucky.

The FDA has approved Revolution Medicines' Rasonque, a once-daily pill targeting RAS protein mutations that drive tumour growth in most pancreatic cancers and roughly a quarter of all human cancers. The drug is priced at $39,800 for a 30-day supply. In trials, patients with previously treated metastatic pancreatic adenocarcinoma who took Rasonque lived a median of 13.2 months, compared with 6.7 months on standard chemotherapy. The drug cut the risk of death by 60%. The approval came 6.5 months before the FDA's deadline. Rasonque is approved for adults with metastatic pancreatic adenocarcinoma who have tried one treatment round or cannot receive combination chemotherapy. Revolution Medicines is advancing the drug through late-stage lung cancer trials. An expanded access programme opened in May has reached more than 2,000 patients.