FDA Gives Full Approval for Tagrisso (osimertinib) for Rare Lung Cancer

James Radke

The FDA has granted full approval of Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. 
Tagrisso (osimertinib) was granted accelerated approval in 2015. The full approval based on data from the randomized, Phase III AURA3 trial.
In the study, 419 patients with T790M-positive advanced NSCLC, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. The primary outcome was progressive-free survival (PFS).
The study found that patients given osimertinib had an improvement in PFS by almost 6 months versus platinum-based doublet chemotherapy (PFS 10.1 months vs 4.4 months, P < .001).
The most common (>20%) adverse reactions observed in osimertinib-treated patients were diarrhea (41%), rash (34%), dry skin (23%), nail toxicity (22%), and fatigue (22%).
The results from this study were published in The New England Journal of Medicine earlier this year.

EGFR T790M-positive advanced NSCLC

Approximately, 10-15% of NSCLC patients have the EGFR mutated form of NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR-tyrosine kinase inhibitors. Approximately two-thirds of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the secondary mutation, T790M.
simertinib is an irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitizing and EGFR T790M resistance mutations and to have activity in the central nervous system (CNS). 
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