The news: The FDA approved a new treatment that significantly extends survival for pancreatic cancer patients. In a 500-patient trial, Revolution Medicines’ Rasonque nearly doubled median overall survival to 13.2 months from 6.7 months with standard chemotherapy among adults with previously treated advanced Stage 4 pancreatic cancer. Some individual trial participants experienced exceptional, long-term responses and survived for years, per The New York Times. Revolution Medicines, which had no FDA-approved drugs before daraxonrasib, began clinical testing of the once-daily pill in 2022.

Why it matters: Though not a cure, the approval marks meaningful progress against a cancer that kills nearly 53,000 Americans annually. Often detected only after it has spread, Stage 4 pancreatic cancer has a five-year survival rate of just 3%. Existing treatments center largely on chemotherapy, which can be physically taxing while extending life only modestly.

Pancreatic cancer is difficult to treat partly because dense scar-like tissue surrounding tumors can limit drugs’ ability to reach cancer cells. Daraxonrasib does not remove this tissue, but has proved capable of reaching tumor cells and blocking RAS, a key growth driver in most pancreatic cancers. About 90% of pancreatic cancers also involve KRAS mutations, long considered difficult to target with drugs, according to Yale Medicine cancer specialists. While newer drugs address individual KRAS mutations and only benefit those patients with each variant, daraxonrasib targets a broad range of variants, potentially expanding its reach. The approach may also have applications in other KRAS-driven cancers, including lung cancer, per Yale, although its effectiveness in those cancers will need to be established separately.

Implications for pharma: Other pharma and biotech companies are testing RAS-targeted therapies in pancreatic cancer, but Rasonque has raised the development bar. Treatments aimed at similar patients may increasingly need to outperform or complement Rasonque rather than compete only with chemotherapy.

Its approval shows that a biotech without a previously approved drug can achieve a breakthrough in a disease where larger drugmakers have struggled, while highlighting the commercial potential of diseases that have seen decades of limited progress. For Revolution Medicines, Rasonque’s near doubling of median survival and lack of effective alternatives could help justify its expected six-figure annual net price benchmark to insurers.

This content is part of EMARKETER’s subscription Briefings, where we pair daily updates with data and analysis from forecasts and research reports. Our Briefings prepare you to start your day informed, to provide critical insights in an important meeting, and to understand the context of what’s happening in your industry. Not a subscriber? Click here to get a demo of our full platform and coverage.