Pharma companies developing treatments for lung cancer should design more nuanced clinical trials that can provide better data about how the drugs are used in combination with surgery, a panel of outside advisors to the FDA unanimously voted on Thursday.
The panel’s 11-0 vote came after hours of discussion about how immune checkpoint therapies like AstraZeneca’s Imfinzi should be administered to early-stage cancer patients who get surgery to remove their tumors. The FDA also asked the experts to weigh in on AstraZeneca’s drug, which the agency is reviewing to decide whether it should be approved before and after surgery for early-stage lung cancer.
As pharmaceutical companies have been pushing their blockbuster cancer drugs into earlier stages of cancer, the FDA has been concerned that trials of checkpoint inhibitors given perioperatively — meaning both before and after surgery — fail to separate out the impact of each part of treatment. According…
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