A historic breakthrough in pancreatic cancer treatment! The FDA approves RevMed, a targeted therapy, with projected sales exceeding $9 billion by 2032.

Revolution Medicines (RevMed)'s new pancreatic cancer drug daraxonrasib has been approved for marketing by the U.S. Food and Drug Administration (FDA), becoming the first targeted therapy against the key molecular pathogenic mechanism of the disease, marking one of the most important breakthroughs in the field of pancreatic cancer treatment in many years.

According to data disclosed by the FDA, in a final-phase clinical trial, daraxonrasib increased the median survival of patients with aggressive pancreatic cancer to 13.2 months, nearly double the 6.7 months of patients receiving chemotherapy (the current standard of care).

"Today's approval provides a crucial new option for patients facing this extremely aggressive and historically difficult-to-treat cancer," said FDA Acting Commissioner Kyle Diamantas.

The drug is marketed under the brand name Rasonque, with an annual price tag exceeding $475,000. Its approved indication is for patients with metastatic pancreatic cancer who have received at least one line of systemic therapy or are ineligible for such therapy.

Following the announcement, RevMed's stock price rose, up 2.5% as of press time, and has more than doubled year-to-date, pushing the company's market capitalization above $45 billion. Wall Street analysts predict the drug's sales could exceed $9 billion by 2032.

The first oral drug that broadly targets RAS proteins

The core value of daraxonrasib lies in its unique mechanism of action.

RAS is a protein closely related to tumor growth and is mutated in the vast majority of pancreatic cancer cases. However, for many years, researchers have been unable to develop drugs that can effectively combat its various variants. RevMed uses an innovative "molecular glue" technology approach to effectively target RAS by encapsulating and inhibiting this dangerous protein.

"This is a huge step forward," said Eileen O'Reilly, an oncologist at Memorial Sloan Kettering Cancer Center and lead author of the final-phase trial, in an interview before the FDA announced its decision.

As a once-daily oral tablet, daraxonrasib also promises to improve the patient experience – patients can take the medication at home without frequent trips to infusion centers, which means more time with family for those with incurable diseases.

RevMed is also advancing clinical trials to explore the feasibility of using the drug in the early stages of the disease.

Patient demand is high; more than two thousand people had already used the drug before it was launched on the market.

Pancreatic cancer has an extremely high mortality rate, with a five-year survival rate of only 13%. According to data from the American Cancer Society, more than 67,000 people will be diagnosed with pancreatic cancer this year, and more than 52,000 will die from the disease.

Market attention surrounding the drug was already quite high even before its official approval. In April of this year, former U.S. Senator Ben Sasse publicly announced that he had been diagnosed with stage IV pancreatic cancer and was taking the drug, which brought widespread attention to daraxonrasib, and RevMed's stock price has more than doubled since April.

The needs of patients and their families were extremely urgent during the approval process. In May of this year, the FDA authorized RevMed to open a Special Extended Access Program, allowing patients who did not meet the enrollment criteria for clinical trials to access the medication. As of early August, RevMed stated that it had provided the medication to more than 2,000 patients through this program.

FDA's expedited review process; pricing not yet announced.

In terms of regulatory processes, daraxonrasib has also been granted "Ultra-Fast Review" designation under the FDA's New Credentials Program, which aims to expedite the approval process for promising drugs.

The FDA stated that the review was completed 6.5 months ahead of the statutory deadline.

The FDA-approved indication also covers patient groups who are not suitable for systemic therapy. The FDA notes that known side effects of the drug include skin rash and mouth ulcers.

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