of patients with early-stage EGFR-mutated lung cancer Tagrisso is the only targeted medicine to show efficacy in the treatment of early-stage lung cancer in a global trial and the first such medicine approved in China where Tagrisso reduced the risk of disease recurrence or death by 80%
AstraZeneca s Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient s physician. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
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ii
80% (n=64)
CI, confidence interval; CR, complete response; DCR, disease control rate; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response
i Includes patients with =1 postbaseline scan or who discontinued treatment.
ii ORR is CR+PR; Responses are confirmed (CRs/PRs; n=32) plus those CRs/PRs too early to be confirmed (n=5).
iii DCR is CR+PR+SD
iv Preliminary PFS limited by earlier censoring by data cutoff due to immature duration of follow-up for 4 and 6 mg/kg dose cohorts.
In the ADAURA Phase III trial, chemotherapy use was balanced across the two treatment arms, with 60% of patients receiving prior adjuvant chemotherapy. In line with uptake observed in prior studies and clinical practice, younger patients (
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TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer
Approval based on unprecedented results from the ADAURA Phase III trial
where TAGRISSO
WILMINGTON, Del. (BUSINESS WIRE) AstraZeneca’s TAGRISSO
® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent. TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis.