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AstraZeneca: Selumetinib Gets US Breakthrough Therapy Designation

AstraZeneca Plc (AZN.L,AZN) announced Thursday that the US Food and Drug Administration has granted Breakthrough Therapy Designation or BTD for the MEK 1/2 inhibitor and potential new medicine selumetinib.

This designation is for the treatment of paediatric patients aged three years and older with neurofibromatosis type 1 or NF1 symptomatic and/or progressive, inoperable plexiform neurofibromas or PN, a rare, incurable genetic condition.

Selumetinib is a MEK 1/2 Inhibitor being co-developed by AstraZeneca and Merck & Co., Inc.,(MRK).

The BTD is based on Phase II data from the SPRINT trial, testing selumetinib as an oral monotherapy in paediatric patients.

The results of the trial were presented by the National Cancer Institute or NCI at the 2018 American Society of Clinical Oncology Annual Meeting.

This is the ninth BTD that AstraZeneca has received from the FDA since 2014.

Selumetinib was granted Orphan Drug Designation for the treatment of NF1 by the US FDA in February 2018 and the European Medicines Agency in August 2018.

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