Why Wall Street sees a $39,800 pancreatic cancer pill as proof of a much bigger bet

The Food and Drug Administration on Wednesday approved Rasonque, a once-daily pill developed by Revolution Medicines to block several forms of the RAS protein — the mutation that drives tumor growth in most pancreatic cancers, and in roughly a quarter of all human cancers overall.

For investors like Dr.

Danish Nagda, an early shareholder in Revolution, the approval matters less for what it does in pancreatic cancer than for what it proves: that a mechanism long considered “undruggable” finally works — and works in one of oncology’s hardest cases.

It’s approved for adults with metastatic pancreatic adenocarcinoma who have already tried one round of treatment or cannot receive combination chemotherapy, and doesn’t require a test to identify a specific RAS mutation first. (Adenocarcinoma is cancer that begins in glandular cells, the cells that line organs and produce substances like mucus, digestive enzymes or hormones.

It’s one of the most common cancer types overall, and in the pancreas specifically, it accounts for 90% to 95% of all cases.) Brian Wolpin, the trial’s principal investigator and director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, said the approval “gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients.” Anna Berkenblit of the Pancreatic Cancer Action Network called it “the most significant advance we have seen in the fight against pancreatic cancer.

Fast-tracked FDA approval The decision came 6.5 months before the FDA’s user-fee deadline, aided by new changes in the agency which let international regulators review oncology applications alongside the FDA.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, director of the FDA’s Oncology Center of Excellence.

In the trial that led to approval, patients with previously treated metastatic pancreatic adenocarcinoma who took the drug lived a median of 13.2 months, compared with 6.7 months on standard chemotherapy, according to the company.

Rasonque cut the risk of death by 60%, and patients went longer before their disease progressed and before pain and quality of life worsened.

The application was reviewed under the FDA’s National Priority Voucher pilot program, and the drug also carries Breakthrough Therapy and Orphan Drug designations — context that explains the compressed timeline without needing the unverified 6.5-month figure.

The drug targets a mutation in the KRAS gene found in nearly all pancreatic cancers and many cases of lung, colorectal and ovarian cancer.

Revolution Medicines is already advancing daraxonrasib through late-stage lung cancer trials.