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FDA Breakthrough Therapy Designation: #38 For AstraZeneca

April 28, 2014

 During AstraZeneca’s first quarter 2014 results announcement on April 24th, the company announces that investigational drug AZD9291 receives on April 16th of this year, the FDA Breakthrough Therapy Designation (BTD).

The BTD is for the treatment of metastatic, Epidermal Growth Receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), where the disease progresses during treatment with an FDA-approved, EGFR Tyrosine Kinase Inhibitor (TKI). The BTD is given based on early clinical trial data from a Phase I study. The Phase I data is to be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting, Chicago, May 30 – June 3, 2014.

This is the 38th BTD announced by a sponsor company, the first BTD for AstraZeneca, and the 3rd BTD for NSCLC :

Num Drug Name Sponsor Company Indication
1 LDK378 Novartis ALK+Non-SmallCell    LungCancer (NSCLC)
2 Dabrafenib GSK Non-SmallCell LungCancer WithBRAF Mutation
3 AZD9291 AstraZeneca Metastatic EGFR T790M mutation-positive NSCLC where the disease progresses during treatment with an FDA-approved EGFR Tyrosine Kinase Inhibitor (TKI)




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Glowing heart (114668824)” by 29cm from Hong Kong (Glowing heart) [CC-BY-SA-2.0] | Wikimedia Commons..

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