25 Apr FDA extends use of Tagrisso to metastatic non-small-cell lung cancer
AstraZeneca’s Tagrisso has been approved by FDA as a first-line treatment for patients with metastatic non-small-cell lung cancer characterized by epidermal growth factor receptor (EGFR) mutations.
Tagrisso is already approved in the US as a second-line treatment for this subgroup of lung cancer patients, whose disease progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation. In trials Tagrisso (osimertinib) significantly improved progression-free survival (PFS) compared to current treatment (18.9 months compared to 10.2 months for those receiving the standard of care). Positive response to Tagrisso was 80% compared to 76% of the current treatment.
Tagrisso is now under regulatory review in the European Union and Japan for use in the first-line treatment setting with regulatory decisions anticipated in the second half of 2018.
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