Don’t Block Progress on Pancreatic Cancer

‍Pancreatic cancer is one of the most unforgiving diseases known to man. Only 13 percent of patients survive for more than five years, and late-stage diagnoses are a virtual death sentence. The disease is responsible for over 8 percent of U.S. cancer deaths, despite accounting for 3 percent of cases. Traditional treatments such as chemotherapy, surgery, and radiation have all improved, but pancreatic cancer remains nearly incurable.

That sounded like a challenge for biotech companies, which, in collaboration with scientists and doctors, are working to make pancreatic cancer a manageable problem. This year, two separate drugs under development are showing immense promise in clinical trials.

The first candidate is daraxonrasib, discovered by Silicon Valley upstart Revolution Medicines. In a Phase 3 trial with 501 enrollees, the drug doubled patients’ life expectancy to 13 months, compared with seven months for those receiving chemo. Six months of added life might not seem like much, but in the pancreatic cancer field, it’s an astonishing triumph.

One patient taking daraxonrasib is former Republican lawmaker Ben Sasse, who announced that he was dying of pancreatic cancer in December. In a recent interview with Ross Douthat, Sasse reported that the drug, amazingly, had shrunk the size of his tumors by 76 percent. The side effects are harsh -- Sasse can no longer produce skin cells, leaving a bloody rash across his face -- but trial participants overwhelmingly elected to continue treatment.

The other pancreatic cancer drug making headlines is sure to be more controversial, though for no good reason. It’s a personalized vaccine involving mRNA technology, of the kind used to develop Covid shots. Like preventive vaccines, the drug instructs a patient’s immune system to recognize and fight foreign invaders. Instead of viruses, the body is trained to attack cancer cells.

BioNTech, one of the companies behind the vaccine, is also the company that worked with Pfizer to develop the first Covid vaccine on the market in 2020. Like Moderna, the firm specializes in mRNA technology, which has the potential to revolutionize medicine by enabling individualized treatments.

It appears to be working well. Of the 16 patients in a Phase 1 trial, eight showed a “dramatic immune response” to BioNTech’s drug. Seven of those eight are still alive six years later -- a nearly 90 percent survival rate. Remember, the prevailing survival rate for pancreatic cancer is just 13 percent.

Daraxonrasib, the non-mRNA drug, is far ahead in the development timeline. Revolution Medicines says it plans to seek regulatory approval soon based on Phase 3 trial results and has secured a fast-track approval process from the Food and Drug Administration (FDA).

Once submitted, the drug should receive a fair and expeditious review, which sadly is not a given. Certain divisions of the FDA have slow-rolled drug approvals under the Trump administration, on the theory that their costs may not justify patient benefits. That’s not a call for bureaucrats to make, but for doctors, insurance providers, and patients themselves. The FDA is empowered to assess drugs’ safety and medical efficacy, and nothing else.

The mRNA-based cancer drug by BioNTech is likely to face more undue scrutiny, so long as Robert F. Kennedy Jr. leads the department overseeing the FDA. Kennedy is implacably hostile to mRNA technology for no justifiable reason. Last year, he ordered the department to cut funding for mRNA vaccines aimed at infectious diseases in favor of older models. The FDA rejected Moderna’s mRNA flu vaccine out of hand -- without even a cursory review -- before reversing course under pressure.

Thanks to biotech innovations, we are closer than ever to finding an effective treatment for pancreatic cancer that allows patients to stay with loved ones for months or years longer. There is a long way to go before mRNA is widely used against cancer and other horrific diseases, but the promise is too great to be jeopardized by one man’s prejudice.

Failing to approve a proven, lifesaving medication would be a moral disaster. Drug regulators must therefore judge mRNA treatments the same as they should any other: on clinical evidence, not unfounded bias.