Pharma Focus Asia
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AstraZeneca Introduces A Breakthrough Therapy-Tagrisso

AstraZeneca introduced Tagrisso (osimertinib), a breakthrough therapy 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).

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the Stage III, unresectable setting (LAURA), in the neoadjuvant resectable setting (NeoADAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).

Lung cancer is the major cause of death in both men and women, accounting for about one-fifth of all cancer deaths. It is classified into NSCLC and small cell lung cancer. Majority of the individuals (80-85%) are affected with NSCLC.Most of the patients affected with NSCLC are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.A significant portion of patients with resectable NSCLC eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.

FDA grants Breakthrough Therapy Designation for Tagrisso in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer. Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries around the world.

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