AstraZeneca Tagrisso has been approved in the EU
Approval based on unprecedented results from phase III ADAURA trial where Tagrisso reduced risk of disease recurrence or death by 80%
AstraZeneca Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early stage non-small cell lung cancer (NSCLC) (IB, II and IIIA) epidermal mutated by epidermal growth factor receptors (m EGFR)) after complete resection of the tumor for curative purposes. Tagrisso is indicated in mEGFR patients whose tumors have exon 19 deletions or exon 21 mutations (L858R).
The approval by the European Commission was based on the positive results of the phase III ADAURA trial in which Tagrisso demonstrated statistically significant and clinically significant improvement in disease-free survival (DFS) in the primary analysis patient population. with stage II and IIIA EGFRm NSCLC. The trial also showed a statistically significant and clinically significant improvement in DFS for Tagrisso in the overall trial population, a key secondary endpoint.
While up to 30% of all patients with NSCLC can be diagnosed early enough to undergo curative surgery, recurrence is still common in the disease at an early stage. Historically, nearly half of patients diagnosed with stage IB and more than three-quarters of patients diagnosed with stage IIIA have experienced disease recurrence within five years.1-3 About one-fifth of patients with lung cancer in the world are in the EU and among those with lung cancer in the world. NSCLC, approximately 15% have tumors with an EGFR mutation. 4-6
Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Spain, said: “In the early stages of lung cancer where resection of the tumor is possible but recurrence is too much. Often, the adjuvant Tagrisso has shown an unprecedented survival benefit for patients with EGFR mutations. I expect this approval to change clinical practice in the EU as it reinforces the critical importance of EGFR mutation testing in all stages of lung cancer to ensure that as many patients as possible benefit from targeted drugs like Tagrisso.
Dave Fredrickson, executive vice president of the Oncology business unit, said: “We know that the earlier a patient’s cancer is detected and treated, the more likely they are to be cured, which is why this approval is important. For the first time, EU patients with EGFR-mutated lung cancer have a targeted, biomarker-based treatment option available in the early stages of their disease that can help them live longer long without cancer. “
In the ADAURA trial, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with stage II and IIIA disease (risk ratio [HR] 0.17; 99.06% confidence interval [CI] 0.11-0.26; p
Consistent DFS results were observed regardless of prior adjuvant chemotherapy use and in all predefined subgroups. The safety and tolerability of Tagrisso in this trial were consistent with previous trials in the metastatic setting. ADAURA’s results were published in the New England Journal of Medicine.
Tagrisso is now licensed to treat early-stage lung cancer in more than fifty countries, including the United States and China, and additional global regulatory reviews are underway. Tagrisso is also approved for the first-line treatment of patients with locally advanced or metastatic mEGFRm NSCLC and for the treatment of locally advanced or metastatic NSCLC with EGFR T790M mutation in the EU, US, Japan, China and in many other countries.
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