publication date: Mar. 31, 2017

Drugs and Targets FDA approves AstraZeneca’s Tagrisso for EGFR mutation-positive NSCLC

FDA granted regular approval to Tagrisso (osimertinib) for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy. 

The drug is sponsored by AstraZeneca Pharmaceuticals LP. 

In November 2015, osimertinib received accelerated approval for this indication based on an overall response rate of 59% among 411 patients in two single-arm clinical trials.  The current approval is based on AURA3 (NCT012151981), a randomized, multicenter open-label, active-controlled trial conducted in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressive disease following first-line EGFR TKI therapy.

All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory. AURA3 randomized 419 patients (2:1) to receive osimertinib (n=279) 80 mg orally once daily or platinum-based doublet chemotherapy (n=140).

Patients in the chemotherapy arm received either pemetrexed, 500 mg/m2 with carboplatin AUC5, or pemetrexed, 500mg/m2 with cisplatin 75 mg/m2), on day 1 of every 21-day cycle for up to 6 cycles followed by pemetrexed maintenance therapy. Patients on the chemotherapy arm with radiological progression according to both investigator and blinded independent central … Continue reading FDA approves AstraZeneca’s Tagrisso for EGFR mutation-positive NSCLC

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