The review of an affordable monoclonal antibody for the treatment of lung cancer, which had already been tested in China, has been blocked in the United States, according to a report from the Daily Wire on Monday. The Food and Drug Administration (FDA) blames the problem on the lack of diversity in trials, with one official even saying last week that they “I want people who look like us in this trial.”
US pharmaceutical giant Eli Lilly and its Chinese partner Innovent recently completed clinical trials of sintilimab, a relatively affordable monoclonal antibody that could extend the lives of people with advanced non-squamous non-small cell lung cancer. . The trial, which took place in China, recruited participants from Asia.
While the drug was due for review by the US Food and Drug Administration last week, all signs pointed to smooth sailing, according to the Daily Wire, which analyzed the written minutes of the meeting in a report published Monday.
Cancer remains one of the top two causes of death in the United States, and the relatively affordable price of the drug makes it even more attractive. But rather than embrace the new drug, Dr. Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, pointed to an insurmountable problem with the study. “Our clinicians, we want people who look like us in this trial, okay,” he said Thursday, noting that he and his colleagues had just celebrated Black History Month.
Padzur went on to say that he believed the trial “does not reflect the ethnic and racial makeup of an American population, particularly with respect to groups traditionally underrepresented in clinical trials.”
Notably, 79% of American patients with the type of cancer the drug is supposed to treat are white, according to the Daily Wire report.
Besides the lack of diversity of Asian subjects, the trial – dubbed Orient-11 – proved to be successful on several levels. Patients who received the drug at the same time as chemotherapy reportedly reduced disease progression by 52% compared to those who received chemotherapy alone, and their risk of death was reduced by 35%. Even more unusual for the high prices expected in American health care, Eli Lilly touted the drug’s affordability as a selling point.
An Innovent official responded by saying that “There is no reason to suggest that safety in US patients would differ from results seen in Orient-11.”
Pazdur, however, reminded the Chinese drugmaker that “the representation of minority ethnic and racial groups is not only a biological reason”, but it is also intended for “Building confidence in clinical trials and post-approval confidence in these drugs that they should be used in these groups.”
Just three years ago, Pazdur himself defended the use of Chinese companies to conduct drug trials, noting that they could be done cheaply abroad and thus lower the prices of new drugs often unaffordable. But during the last “two to three years” he observed on Thursday, “This country has seen significant social change and there has been a huge outcry for diversity in clinical trials and representation.”
As a public agency, the FDA has 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 saw as the flaw in Pazdur’s argument, pointing out that “this drug works” and “I think health equity will improve when there are fewer cost barriers to care.” Panelist Dr. Jorge Nieva went on to say that “Having more drugs competing for these same patients will, I think, have a greater impact on equity than the need for diversity in clinical trial recruitment.”
Although the FDA submission acknowledged that there was no reason to believe the drug would work any differently in Chinese subjects than in white American subjects, a statement in the Innovent study specifically suggested that the body of black patients would actually respond to the drug in a way more similar to their Chinese counterparts than to white patients. However, the FDA apparently omitted this part of its presentation.
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