Revolution Medicines’ Pancreatic Cancer Drug Rasonque Wins U.S. Approval, With ‘Historic Launch’ Expectations and Pricing and Labeling Challenges

While physicians and investors are anticipating a “historic launch” following the U.S. approval of Rasonque, a new pancreatic cancer drug, challenges including its high price and unclear eligibility criteria remain to be addressed.

According to Fierce Pharma on the 28th local time, Revolution Medicines (RevMed) said it had received U.S. Food and Drug Administration (FDA) approval for Rasonque (generic name daraxorasib), a treatment for metastatic pancreatic cancer.

Dr. Ajaz Khan, a medical oncologist at City of Hope in Chicago, said he was “surprised” by the approval news but added that he hoped “a brighter future will open up for patients and their families, as well as the communities in which they live.”

Dr. Khan was present this summer at the American Society of Clinical Oncology (ASCO) meeting when Revolution Medicines received a standing ovation for its pancreatic cancer data. He described it as “a truly remarkable time in which we live.”

Revolution Medicines CEO Mark Goldsmith also emphasized during an investor conference call that “today marks a historic advance for patients with metastatic pancreatic cancer,” adding that “this approval validates more than a decade of research aimed at targeting pancreatic cancers driven primarily by Ras gene mutations.”

The market had anticipated Rasonque’s blockbuster potential early on. Evercore ISI analysts projected that sales would reach $1.76 billion (approximately 264 billion won) in 2027, while Guggenheim Securities forecast a sharp increase from approximately $900 million (approximately 135 billion won) next year to $2.2 billion (approximately 330 billion won) in 2028.

Evercore analysts said they “continue to anticipate a potentially historic oncology launch,” adding that “Rasonque has the ingredients to become the fastest oncology launch in history.”

The speed of the launch will depend on how quickly patients participating in the expanded access program (EAP) can be converted to commercial customers. Jefferies analysts expected half of them to convert in the first month, followed by an additional 10% each month.

Anthony Mancini, Revolution Medicines’ chief global commercialization officer, expected the conversion to take several months. He said the company would “work closely with the physicians responsible at every institution to support the transition to commercial therapy at a clinically appropriate time,” adding that “the EAP portal will close today but will remain available during a limited transition period, with the goal of supporting continuity of treatment for eligible patients.”

However, the biggest obstacle as patients transition to customers is Rasonque’s high price.

Revolution Medicines set the price for a 30-day supply at $39,800 (approximately 59.7 million won) before discounts and rebates, based on the recommended daily dose of 300 mg.

Mancini said, “This price reflects the unprecedented overall survival benefit demonstrated in the RASolute 302 trial and the broad clinical value.”

Jack Anders, the company’s chief financial officer, said he expected most eligible patients to receive coverage through government insurance programs such as Medicare.

For patients without insurance coverage, Revolution Medicines established a patient assistance program called OnPath. Designed to provide $0 out-of-pocket costs, the program supports both patients participating in the EAP and new patients.

Mancini said, “It is a voluntary program, and patients enroll directly,” adding that it “will be offered very broadly, and we expect a high participation rate.”

Dr. Khan noted that the ultimate responsibility for ensuring access to the drug rests with Revolution Medicines. He said, “This is a completely new company whose first drug this is, not a company like Merck or Genentech that has made hundreds of drugs over many years,” adding, “The bigger question is how Revolution Medicines handles this.”

According to Revolution Medicines, academic medical centers such as City of Hope account for approximately 40% of the Rasonque market. Although Dr. Khan was confident that oncologists at his hospital would prescribe the drug actively, he expected more dedicated outreach would be needed to reach oncologists at community medical centers, particularly those in rural areas.

Mancini said, “Because 60% of patients receive treatment in community oncology practices, broad community education and engagement at the practice level are equally important,” adding, “We have built a world-class commercialization organization with deep experience in oncology, oral anticancer drugs, gastrointestinal cancers and new product launches, and our U.S. medical science liaisons (MSLs) have been active for more than a year, engaging clinical experts through scientific exchange.”

Meanwhile, Revolution Medicines is moving to make Rasonque available to patients with pancreatic cancer who have received prior treatment while also accelerating clinical trials to demonstrate superiority over chemotherapy in the first-line setting. Dr. Khan described this as one of the major challenges remaining for the company and a key to fully unlocking Rasonque’s megablockbuster potential.

Rasonque’s approved indication primarily covers “adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy,” but the FDA also authorized its use in “patients who are not candidates for multiagent systemic therapy.”

The problem is that no one knows exactly what this criterion means.

Chief development officer Alan Sandler said, “The U.S. prescribing information does not define specific criteria for determining whether a patient is a candidate for multiagent systemic therapy,” adding that “treatment decisions among the approved options should be made by the treating physician in consultation with the patient.”

Analysts viewed the broader-than-expected indication positively despite uncertainty about how it will be applied in actual clinical practice.

Guggenheim analysts said, “The approved indication is a slightly more flexible version of the enrollment criteria for RASolute 302, representing an upside scenario,” adding that “in the best case, approval does not require testing for Ras mutations.”

According to analysts, Revolution Medicines has estimated that 25% of patients with metastatic pancreatic cancer do not receive chemotherapy as their initial treatment.

Dr. Khan said the significance of the first-line treatment option would ultimately depend on cancer treatment guidelines and whether insurers provide coverage. He said, “We now need to talk with the insurers who pay for this drug, and we also need to discuss the guidelines,” adding, “It will clearly be an interesting conversation.”