Tagrisso approved in China as first-in-class treatment for EGFR T790M mutation-positive metastatic non-small cell lung cancer

First AstraZeneca medicine approved under China’s new Priority Review pathway

Tagrisso is an important new medicine in a country where lung cancer is the leading cause of cancer-related deaths and EGFR-mutation rates are among highest globally

27 March 2017

AstraZeneca today announced that the China Food and Drug Administration (CFDA) has granted marketing authorisation for Tagrisso (osimertinib) 40 mg and 80mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Lung cancer is the most common form of cancer and the leading cause of cancer-related deaths in China.¹ Approximately 30-40% of Asian patients with NSCLC have the EGFR mutation at diagnosis, and nearly two thirds of these patients whose disease progresses after treatment with an EGFR TKI develop the T790M mutation.^2,3

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “This is an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients with NSCLC in China, where EGFR mutation rates are some of the highest in the world.”

Eligibility for treatment with Tagrisso requires the patient’s EGFR T790M mutation status to be determined with a validated test using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample (blood test).

Tagrisso is the first AstraZeneca medicine approved under the CFDA’s Priority Review pathway, using an accelerated timeline for an innovative medicine. The rapid review and approval signal the urgent need for new, targeted treatments with the potential to address specific types of cancer with high incidence rate and significant unmet medical need in China. They are also a recognition by the CFDA of the accelerated reform of China’s regulatory framework to benefit Chinese patients.

NOTES TO EDITORS

About AstraZeneca in China

Since entering China in 1993, AstraZeneca has been committed to continuously following the science, focusing on innovation and becoming one of the most trusted healthcare partners in improving the lives of Chinese patients. AstraZeneca’s China headquarters are based in Shanghai, and the company has more than 11,000 employees throughout the country. AstraZeneca has end-to-end R&D capabilities in China, from discovery through to clinical development and manufacturing of innovative medicines to address the unique needs of patients in Asia. This comprehensive presence includes manufacturing sites in Wuxi and Taizhou, a China Distribution Centre in Wuxi and an Innovation Centre in Shanghai. China is AstraZeneca’s second largest market globally, with revenue of $2.6 billion in 2016.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.⁴ Among patients with NSCLC, 20% to 40% have brain metastases at some time during the course of their disease.⁵ Patients who have the EGFRm form of NSCLC, which occurs in 10-15% of NSCLC patients in the US and Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells.^2,6,7,8 However, tumours almost always develop resistance to treatment, leading to disease progression.⁹ Approximately two-thirds of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the secondary mutation, T790M.⁹

About Tagrisso

Tagrisso (osimertinib) 40 mg and 80mg once daily oral tablet has been approved in over 45 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced non-small cell lung cancer (NSCLC). Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumour.

Tagrisso is a third generation, irreversible EGFR inhibitor designed to inhibit both EGFR sensitising and T790M resistance mutations and to have activity in the central nervous system (CNS). Tagrisso is also investigated in the adjuvant and metastatic 1st line settings, including in patients with and without brain metastases, in leptomeningeal disease, and in combination with other treatments.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

CONTACTS

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^{3 Sharma SV, et al. Epidermal Growth Factor Receptor Mutations in Lung Cancer. Nat Rev Cancer. 2007;7:169-181.}

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^{6 Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-12.}

^{7 Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011;29:2121-27.}

^{8 Langer CJ, et al. Epidermal Growth Factor Receptor Inhibition in Mutation-Positive Non-Small-Cell Lung Cancer: Is Afatinib Better or Simply Newer? Journal of Clinical Oncology. 2013;31(27);3303-3305.}

^{9 Yu HA, et al. Analysis of Tumour Specimens at the Time of Acquired Resistance to EGFR-TKI Therapy in 155 Patients with EGFR-Mutant Lung Cancer. Clin Cancer Research. 2013:19(8):2240-2246.}