publication date: Nov. 13, 2015

Tagrisso Granted Accelerated Approval

in Non-Small Cell Lung Cancer 


FDA granted accelerated approval to Tagrisso (osimertinib) tablets 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, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

The approval was based on two multicenter, single-arm, open-label clinical trials in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI. All patients were required to have EGFR T790M mutation-positive NSCLC as detected by the cobas EGFR mutation test and received osimertinib 80 mg once daily.

The major efficacy outcome measure was objective response rate according to RECIST v1.1 as evaluated by a Blinded Independent Central Review. Duration of response was an additional outcome measure.

The first study (n=201) showed an ORR of 57 percent (95% CI: 50%, 64%). The second study (n=210) demonstrated an ORR of 61 percent (95% CI: 54%, 68%). The majority, 96 percent, of patients in both trials had ongoing responses at the time of primary analysis, and the median DOR had not been reached, with duration of ongoing responses ranging from 1.1 to 5.6 months after a median duration of follow-up of 4.2 months in Study 1 and 4.0 months in Study 2. The dose finding phase of Study 1 (n=63) showed an ORR of 51 percent and median DOR of 12.4 months.

Safety data was evaluated in 411 patients who received osimertinib at a dose of 80 mg daily. The … Continue reading 41-42 Tagrisso Granted Accelerated Approval in Non-Small Cell Lung Cancer

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