(AbsoluteNews.com) – In February, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 to require more clinical trials before approving a particular cancer drug. Pharmaceutical giant Eli Lilly had only tested the medication, Sintilimab, in China. Recently, the agency made a final decision about the drug.
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On March 24, Eli Lilly revealed the FDA had refused to approve its application for the lung cancer drug. Sintilimab is an immunotherapy that works with chemo to treat patients who’ve been diagnosed with nonsquamous non-small cell lung cancer. The clinical trials for the medication, which had been developed with China-based Innovent Biologics, only took place in the communist country.
During the February hearing, FDA officials revealed concern about the methodology used for testing. For instance, the study used progression-free survival (PFS) instead of the overall survival (OS) rate to measure how well the drug performed. The OS rate is how long patients survive after receiving treatment, while the PFS is the time from when patients receive treatment until their conditions get worse. In other words, using the OS rate could show more endpoint results.
Eli Lilly hasn’t said how it will move forward with the drug application. Do you agree with the FDA’s decision?
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