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AstraZeneca, the Anglo-Swedish pharma major, has now been awarded breakthrough status in the US for its drug candidate, Tagrisso, as a first-line treatment for a specific type of non-small cell lung cancer (NSCLC), potentially speeding up its development and regulatory pathway.

The Breakthrough Therapy Designation means the FDA has determined, based on clinical data provided, that the drug may offer substantial treatment advantages over existing options. The Breakthrough status means the drug will be given priority review when its drug application is accepted by the FDA for examination (i.e., the review process will take 6 months instead of 10 months).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “The Breakthrough Therapy designation acknowledges not only osimertinib’s potential as a first-line standard of care in advanced EGFR mutation–positive NSCLC, but also the significant need for improved clinical outcomes in this disease. The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.

The FDA granted the Breakthrough Therapy designation based on data from the phase III FLAURA trial of osimertinib vs the standard of care—EGFR tyrosine kinase inhibitor therapy—in previously untreated patients with locally advanced or metastatic EGFR mutation–positive NSCLC. In the trial, median progression-free survival was 18.9 months for osimertinib compared with 10.2 months for the EGFR tyrosine kinase inhibitors erlotinib (Tarceva) or gefitinib (Iressa). Improvements were seen in all prespecified subgroups, including patients with and without brain metastases.

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Osimertinib (Tagrisso), is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system (CNS) metastases. Frontline osimertinib was associated with a 54% reduction in the risk of progression or death compared with standard therapy, according to phase III data from the FLAURA study presented at the 2017 ESMO Congress.

In a separate release the company also announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The MAA submission was based on encouraging data from phase III PACIFIC study. Imfinzi has already received accelerated approval in the United States for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

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