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On Friday, the FDA expanded AstraZenecom's Tagrisso (osimertinib) range to allow Tagrisso (osimertinib) to treat patients with non-small cell lung cancer (NSCLC) with the EGFR exon 19 missing or exon 21 L858R mutation.
, director of the FDA's Center for Drug Evaluation and Research, commented, "With approval, this targeted therapy can be accepted at an earlier stage of non-small cell lung cancer."
the approval is based on data from the ADAURA Random Phase III clinical trial, which included 682 patients with EGFR exon 19 missing or exon 21 L858R mutations with non-small cell lung cancer (NSCLC) mutations, the main endpoint of which was disease-free survival.
showed that tagrisso (osimertinib) reduced the risk of recurrence by about 80 percent compared to placebo.
Tagrisso has been approved in the United States for first-line treatment of metastasis NSCLC patients with EGFR exon 19 missing or exon 21 L858R mutation, has also been used in second-line treatment to treat metastasis EGFR T790M mutation-positive NSCLC patients.
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