FDA Slows Approval of Affordable Cancer Drug in the Name of Racial ‘Equity’

An effective and more affordable treatment for lung cancer may not gain approval after the Food and Drug Administration (FDA) complained about the lack of black people in its clinical trial, with a top FDA cancer official repeatedly noting in a meeting that it is Black History Month.

Eli Lilly and a Chinese partner called Innovent believe the drug, known as Tyvyt or sintilimab, could extend the lives of those suffering with late-stage non-squamous non-small cell lung cancer (NSCLC), and be more affordable than other treatments. The clinical trial patients were Asian because the trial was conducted in China.

But at a meeting Thursday to decide whether the drug’s application for U.S. approval was satisfactory, Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said “We just had a meeting yesterday with external groups to celebrate Black History Month and the primary thing that many people said, and I’m sure all of you on this call have heard it, that our clinicians, that our clinicians, we want people that look like us on this trial, okay.”

“I’m very unhappy to have this conversation on this month which is obviously Black History Month. I think we really have to do a better job of this. We have several programs at the FDA on this, including Project Equity, trying to address this issue,” he said.

In the study, called the Orient-11 trial, patients receiving Tyvyt along with chemo reduced disease progression by 52% compared to chemo alone, and reduced the risk of death by 35%. Fierce Pharma noted prior to the meeting that Eli Lilly has made the drug’s affordability a prime selling point, boasting of its “disruptive pricing strategy.”

Padzur said the trial “does not reflect the ethnic and racial make up of a U.S. population notably with regard to groups traditionally underrepresented in clinical trials.”

If there is harm from a trial being done with people of a different race, though, by far the biggest group affected would seem to be whites, not blacks who are “traditionally underrepresented.” In the U.S., 79% of patients with non-squamous NSCLC are white.

An Innovent official said “There’s no reason to suggest that the safety in the U.S. patients would differ from the results observed in ORIENT-11.”

But Pazdur said “the representation of ethnic and racial minority groups is not just a biological reason we want people on these trials, it’s to build confidence in the clinical trials and a confidence after these drugs are approved that they should be used in these groups,” he said. An FDA presentation added that non-biological “ethnic factors” may impact drug efficacy, such as smoking, alcohol, food habits, and “drug compliance.”

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The FDA presented its concerns to a panel of experts who were charged with voting on how to deal with the request to proceed with approval in the U.S. One panelist, Dr. Jorge Nieva, critiqued their logic, arguing that bringing a low-cost, life-saving drug to market would help all groups, especially impoverished ones.

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But after the negative presentation from the FDA and Pazdur’s comments, all the other panelists voted “no.” The vote could have an effect on many more drugs. {snip}

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