A Food and Drug Administration (FDA) advisory panel today said “no” to a proposal to limit use of ACTIVELIFE’s COVID-19, an oral drug designed to boost the immune system’s effectiveness against cancer.
The COVID-19, which is comprised of a synthetic peptide mixture, was based on a lethal dose of the disease’s experimental compound, imatinib, which is already approved for patients with certain blood cancers who are in their late-30s and older.
After the panel voted to recommend the drug’s use, ACTIVElife Inc. said it plans to submit a new application for clinical trials at an age lower than the initial proposal to target patients ages 60 to 70 with lung and colorectal cancer, the biggest cancer types in the United States.
Routine post-approval monitoring will also be required, which would be necessary to ensure younger patients have responded well to the drug.
But researchers said there are far fewer people eligible for the trial, which was initially proposed for patients who had either gotten final-stage or squamous-cell cancers. Because of the expanded trial, ACTIVElife said it would consider other studies, including one that would target younger people with non-small-cell lung cancer or bladder cancer.
The company said it will decide which patients to include in the trials in the next 30 days.
For half of the panel’s 9 members, the debate came down to a risk-benefit balancing scale that can easily pit patients’ benefits against potential risks.
But for the other half, the debate was about replacing an experimental drug that would only work on about 20 percent of patients with an oral drug that doctors had never administered before.
“The ongoing research here does not completely preclude a pediatric trial, and we are ready to act on a pediatric trial as soon as the time comes,” said Francis Collins, director of the National Institutes of Health.
While the FDA normally follows the recommendations of panelists, it isn’t obligated to do so.
For some of the drug’s supporters, the resistance to the drug is puzzling given that multiple trials have suggested it may be safe and effective. ACTIVElife reported the COVID-19 had nearly as strong an effect on non-small-cell lung cancer patients and had no serious safety issues.
There is also debate whether there are far fewer lung cancer cases than many doctors think.
For many on the panel, it was about the decision to limit use.
“We would like you to encourage ACTIVElife to see the majority of clinical trials for COVID-19 include patients under 65,” Dr. Jules Barabanov of Georgetown University’s Lombardi Comprehensive Cancer Center told the panel.
But for the many opponents, the numbers don’t mean much because the results that have been reported have not been conclusive. They hope more peer-reviewed data will convince the FDA to go for the full 270-patient trial proposed in March.
“I don’t believe this drug is as safe as ACTIVElife is making it out to be,” said Dr. Robert Stone of George Washington University.
Dr. Steven Goldman, a professor of immunology at Yale University Medical School, said he worries the drug will come to be considered the “gold standard” for boosting a patient’s immune system and slow down the age-old risks of cancer.
And Dr. Walter Kolodjay of the University of Texas Health Science Center San Antonio, who presented the most convincing data of the four-person panel, said ACTIVElife’s drug is “too good to be true.”
He said it has only been tested on a handful of patients, and the company hasn’t been able to track safety issues the same way standard FDA clinical trials do.
“We’re not going to find more people benefiting, but if the drug gets approved we could find hundreds more dying,” he said.
Bob Allen, a former Army officer and MBA, is a CNN political analyst.