Revolution's ASCO showstopper gets FDA greenlight

Revolution Medicines' Rasonque (daraxonrasib), the RAS inhibitor that received a standing ovation at ASCO for its doubling of overall survival in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), has now gotten the approval that really counts -- FDA approval that will allow the company to begin marketing the once-a-day tablet.

The drug is approved for patients who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” Acting FDA Commissioner Kyle Diamantas said in a statement. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”

Mere months ago, data was presented at ASCO 2026 in Chicago that ASCO Chief Medical Officer Julie Gralow described as "not just a home run but a grand slam": a median overall survival of of 13.2 months, compared to 6.7 months with investigator's choice of second-line chemo and a progression-free survival of 7.2 months vs 3.6 in the comparator group.

"The unprecedented results of the global Phase 3 trial position Rasonquq to become the new standard of care for patients with metastatic pancreatic cancer under an approved label that supports real-world clinical decision-making," said Revolution Medicines CEO Dr Mark Goldsmith. "This approval further validates our bold RAS(ON) inhibitor strategy that includes multi-selective and mutant-selective approaches targeting a major driver of pancreatic cancer and multiple other cancers. We continue to engage with global regulatory authorities with the goal of expanding and accelerating the reach of Rasonque."

Thanks to a national priority review voucher, Revolution Medicines was able to move quickly through the FDA process.

“This drug showed unprecedented results in an area of high unmet need,” Dr Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said in a statement. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”

In addition to being very hard to treat, pancreatic cancer is one of the tumour types most driven by RAS mutations, which are seen in around 90% of all cases and fuel aggressive tumour invasiveness and growth. That's led to a lot of comers in the pan-RAS inhibitor space, but Revolution has found itself comfortably in the head of the pack.

The company's stock did not move meaningfully on the news of the approval however -- possibly because analysts were hoping for a first-line, rather than second-line, indication, according to RBC Capital Markets analyst Leonid Timashev.