AstraZeneca plc (ADR)(NYSE:AZN) Tagrisso Granted Breakthrough Therapy Designation

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AstraZeneca plc (ADR) (NYSE:AZN) has revealed that a Breakthrough Therapy Designation has been granted to its lung cancer drug known as Tagrisso by the U.S. Food and Drug Administration. At the moment Tagrisso is approved for use as a second-line treatment in patients suffering from NSCLC – non-small cell lung cancer in China, Japan, the European Union and the United States.

The designation was granted after a phase III study which evaluated Tagrisso in comparison with tyrosine kinase inhibitor treatment in a first-line lung cancer environment. Results of the study revealed that following the use of Tagrisso, there was a reduction in the progression risk or the likelihood of dying by over half. The median for progression-free survival patients who were put on Tagrisso was approximately 18.9 months. Patients who were put on the other treatment had a progression-free survival median of 10.2 months.

Safety profile

Participants in the study showed tolerance and the drug had a safety profile that was the same as in the previous experience. As a result of receiving the Breakthrough Therapy Designation the development and review of the drug will be expedited as this designation is meant for drugs that have the capacity to treat rare and serious diseases.

Additionally AstraZeneca has revealed that an MAA – Marketing Authorization Application, sent to the European Medicines Agency for a drug known as Imfinzi has been accepted. Imfinzi is used in the treatment of unresectable NSCLC which has failed to progress after chemoradiation therapy that is platinum-based.

Label expansion

The data used in the MAA submission was encouraging and was derived from the phase 3 PACIFIC study. In the United States Imfinzi has been granted accelerated approval by the Food and Drug Administration in the treatment of patients suffering from metastatic urothelial carcinoma and whose disease progresses during or after platinum-containing chemotherapy.

It is also for use in patients whose disease has progressed within one year of undergoing platinum-containing chemotherapy either before or after surgery. An expected expansion of the label is expected to boost revenues of AstroZeneca.

On Monday shares of AstraZeneca Plc edged up by 0.64% to close the day at $34.48 a share.

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