Ebene News – EN – ADDING MULTIMEDIA TAGRISSO Approved in the United States for the adjuvant treatment of patients with early stage lung cancer mutated by EGFR

Approval based on unprecedented results from phase III ADAURA trial where TAGRISSO reduced risk of recurrence or death by 80%

WILMINGTON, Suppr- (BUSINESS WIRE) – TAGRISSO® (osimertinib) from AstraZeneca has been approved in the United States for the adjuvant treatment of adult patients with mutated non-small cell lung cancer (NSCLC) by the epidermal growth factor receptor (mEGFR) at an early stage tumor resection for curative purposes TAGRISSO is indicated in mEGFR patients whose tumors have deletions of exon 19 or mutations of exon 21 L858R detected by a approved test

Approval granted under the United States Food and Drug Administration (FDA) Real-Time Oncology Real-Time Review (RTOR) pilot program Five more countries participated in a simultaneous submission and review process under the FDA’s Orbis project

While up to 30% of all patients with NSCLC can be diagnosed early enough to undergo potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed with stage IB and more than three quarters of patients diagnosed with stage IB IIIA, recurrence within five years1-4

The approval was based on the results of the phase III ADAURA study where TAGRISSO demonstrated statistically significant and clinically significant improvement in disease-free survival (DFS) in the primary analysis population of patients with mNSCLC EGFR stage II and IIIA, as well as the overall trial population of patients with stage IB-IIIA disease, a key secondary endpoint

Roy S Herbst, MD, PhD, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the phase III ADAURA trial, said, “The adjuvant TAGRISSO has demonstrated unprecedented disease-free survival benefit for stage lung cancer patients with EGFR mutations who face high rates of recurrence even after successful surgery and subsequent chemotherapy This approval reinforces how it is essential to test all lung cancer patients for EGFR mutations before deciding how to treat them and whatever their stage at diagnosis This will help ensure that as many patients as possible can benefit from this practice-changing treatment ”

Dave Fredrickson, executive vice president of the Oncology division, said: “For the first time, a targeted, biomarker-based treatment option is available in the United States with early stage lung cancer mutated by the ‘EGFR This approval dispels the idea that treatment is over after surgery and chemotherapy, as ADAURA results show that TAGRISSO can dramatically change the course of this disease We remain committed to treating cancer patients earlier, when they may still have a chance to be cured. ”

Adjuvant treatment with TAGRISSO reduced the risk of disease recurrence or death by 83% in the primary endpoint of DFS in patients with stage II and IIIA disease (hazard ratio [HR] 017; 95% Confidence Interval [CI] 012-023; p <00001) The results of DFS in the overall trial population of patients with stage IB-IIIA disease showed that TAGRISSO reduced the risk of recurrence of 80% disease or death (HR 020; 95% CI 015-027; p <00001) At two years, 89% of patients treated with TAGRISSO remained alive and disease free versus 52% on placebo after surgery , the current standard of care The safety and tolerability of TAGRISSO in this trial was consistent with previous trials in the metastatic setting

TAGRISSO recently received breakthrough therapy designation for patients with early stage disease by the US FDA.In April 2020, an independent data monitoring committee recommended that the ADAURA trial be terminated two years earlier on the basis of overwhelming efficiency determination Investigators and patients continue to participate in the trial and remain blind to treatment The results of the ADAURA trial were presented at the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Science Program in May 2020 and have recently published in the New England Journal of Medicine

The US regulatory submission has been reviewed as part of the FDA’s RTOR pilot program which aims to ensure that safe and effective treatments are available to patients as early as possible. Five national health authorities collaborated with the FDA on this review through Project Orbis, an initiative of the FDA’s Center of Excellence for Oncology, which provides a framework for the simultaneous submission and review of oncology drugs among partners. international These included Health Canada, the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency (Anvisa), Swissmedic and the Singapore Health Sciences Authority. The UK Medicines and Health Products Regulatory Agency participated in the review as an observer

In China, TAGRISSO is under priority review for adjuvant treatment of patients with early-stage mEGFR m NSCLC based on the phase III ADAURA trial This indication is also under regulatory review in the EU and further global bid discussions are underway

TAGRISSO is a once-daily oral tablet approved for the first-line treatment of patients with metastatic EGFRm NSCLC and for the treatment of metastatic EGFR T790M mutation positive NSCLC in the United States, Japan, China, the EU and in many other countries of the world

Lung cancer is the leading cause of cancer death in both men and women, accounting for about a fifth of all cancer deaths5 Lung cancer is broadly divided into NSCLC and small cell lung cancer, 80-85% being classified as NSCLC6 The majority of all patients with NSCLC are diagnosed with advanced disease, while about 25-30% have resectable disease at the time of diagnosis1-3

For those with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy4 Diagnoses of early-stage lung cancer are often not made until the cancer is detected at the imaging for an unrelated condition7,8

Approximately 10-15% of patients with NSCLC in the United States and Europe, and 30-40% of patients in Asia have EGFRm9-11 NSCLC These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKI) which block cell signaling pathways that stimulate tumor cell growth12

ADAURA is a randomized, double-blind, comprehensive, placebo-controlled phase III study in the adjuvant treatment of 682 patients with stage IB, II, IIIA mEGFRM NSCLC after complete tumor resection and adjuvant chemotherapy as indicated. been treated with TAGRISSO 80 mg oral tablet once daily or with placebo for three years or until disease recurrence

The trial was recruited from more than 200 centers in more than 20 countries including the United States, Europe, South America, Asia and the Middle East Primary endpoint was DFS in patients stage II and IIIA and a key secondary endpoint was DFS in patients with stage IB, II and IIIA Data reading was originally scheduled for 2022 Trial will continue to assess overall survival

TAGRISSO® (osimertinib) is a third generation irreversible EGFR-TKI with clinical activity against central nervous system metastases TAGRISSO 40 mg and 80 mg oral tablets once daily have been approved in the United States, Japan, in China, the EU and many countries around the world for metastatic 1st-line EGFRm NSCLC and metastatic EGFR T790M mutation positive NSCLC

AstraZeneca has a comprehensive portfolio of approved and potential new drugs in advanced development for the treatment of different forms of lung cancer spanning different histologies, multiple disease stages, lines of therapy and modes of action.

AstraZeneca aims to address the unmet need of patients with mEGFR tumors as a genetic driver of disease with the approved drugs gefitinib and TAGRISSO, and its ongoing phase III trials LAURA, NeoADAURA and FLAURA2

AstraZeneca is committed to tackling tumor resistance mechanisms through ongoing phase II trials SAVANNAH and ORCHARD which test TAGRISSO in combination with savolitinib, a selective inhibitor of the c-MET receptor tyrosine kinase, as well as other new potential drugs

AstraZeneca has a deeply rooted heritage in oncology and offers a rapidly growing portfolio of new drugs with the potential to transform patients’ lives and the future of the business. With seven new drugs launched between 2014 and 2020 and a broad portfolio of small molecules and biologics in development, the company is committed to advancing oncology as a key growth engine for AstraZeneca, focused on cancers of the lung, ovary, breast and blood

By harnessing the power of six scientific platforms – immuno-oncology, tumor factors and resistance, DNA damage response, antibody drug conjugates, epigenetics and cell therapies – and advocating developing personalized combinations, AstraZeneca has a vision to redefine cancer treatment and one day eliminate cancer as the cause of death

AstraZeneca is a global science-led biopharmaceutical company focused on the discovery, development and commercialization of prescription drugs, primarily for the treatment of diseases in three therapeutic areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients around the world For more information, please visit https: // wwwastrazeneca-uscom / and follow us on Twitter @AstraZenecaUS

Osimertinib, AstraZeneca, Food and Drug Administration, non-small cell lung cancer, oncology, lung, adjuvant therapy

Ebene News – EN – ADDING MULTIMEDIA TAGRISSO Approved in the US United for the adjuvant treatment of patients with early stage lung cancer mutated by EGFR

Source: https://www.businesswire.com/news/home/20201221005157/en/ADDING-MULTIMEDIA-TAGRISSO-Approved-in-the-US-for-the-Adjuvant-Treatment-of-Patients-With-Early-Stage-EGFR-mutated-Lung-Cancer