A monoclonal, affordable antibody drug to treat lung cancer has been stopped by the US. It had been successfully tested previously in China. The Food and Drug Administration (FDA) explains the issue by the trials’ lack of diversity, with an official even saying last week that they “want people that look like us on this trial.”
US pharma giant Eli Lilly and its Chinese partner Innovent recently completed clinical trials of sintilimab – a relatively affordable monoclonal antibody drug that could extend the lives of individuals with late-stage non-squamous non-small cell lung cancer. Asian patients were included in this trial that took place China.
All signs indicated that the US Food and Drug Administration would review the drug as soon as possible, last week. According to the Daily Wire which examined the minutes of the meeting and published an article Monday.
Cancer remains one of the top two causes of death in the US, and the drug’s relative affordability made it even more appealing. But rather than embrace the new drug, Dr. Richard Pazdur, the director of the Food and Drug Administration’s Oncology Center of Excellence, pointed to one insurmountable problem with the study. “Our clinicians, we want people that look like us on this trial, okay,”On Thursday, he stated that he had just observed Black History Month with his colleagues.
Padzur continued to state that he was convinced by the trial “does not reflect the ethnic and racial makeup of a US population notably with regard to groups traditionally underrepresented in clinical trials.”
Notably, 79% of US patients with the type of cancer the drug is meant to treat are white, according to the Daily Wire’s report.
Aside from the lack of diversity of the Asian test subjects, the trial – dubbed Orient-11 – appeared successful on multiple levels. Patients receiving the drug in combination with chemotherapy were reported to experience a 52% reduction in disease progression compared to those who got only the chemotherapy. The risk of dying was also reduced by 35%. Eli Lilly, despite the high price of American healthcare, was touting its affordability as an advantage.
A representative from Innovent responded with the following: “There’s no reason to suggest that the safety in the US patients would differ from the results observed in Orient-11.”
Pazdur however has reminded Chinese drugmaker China that “the representation of ethnic and racial minority groups is not just a biological reason,” but it’s also meant to “build confidence in the clinical trials and a confidence after these drugs are approved that they should be used in these groups.”
Pazdur, who was just three years old, advocated the use Chinese companies to carry out drug trials. This is because they were cheaper and could lower the price of many of today’s unaffordable drugs. Over the past few years, however, Pazdur has changed his mind. “two to three years,”On Thursday, he noted that “this country has experienced significant social changeAnd there has been a tremendous outcry for diversity in clinical trial and representation.”
We as a public agency, the FDA have to adhere to what patients want in the United States… So we have a huge commitment to diversity.
Only one member of the expert panel to whom the FDA presented its concerns last week called out what he viewed as the flaw in Pazdur’s argument, pointing out that “this drug works” and “health equity I think will improve when there are fewer cost barriers to care.”Jorge Nieva, panelist, continued to say that “having more drugs competing for those same patients will have, I think, greater impact on equity than the need for diversity in clinical trial enrollment.”
While the FDA’s presentation did acknowledge there was no reason to believe the drug would work differently on Chinese subjects than on white American subjects, a statement in the Innovent study had specifically suggested that black patients’ bodies would actually respond to the drug in a manner more similar to their Chinese counterparts than to white patients. However, the FDA apparently left out that part of its presentation.
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