AstraZeneca’s Selumetinib Receives the US FDA’s Breakthrough Therapy Designation for Neurofibromatosis Type 1

Shots:

• The BT Designation follows the P-II SPRINT trial assessing selumetinib as a monothx (PO) in paediatric patients, aged three years or older with inoperable NF1-related PN
• The ninth BT designation is granted to the AstraZeneca for the MEK 1/2 inhibitor and the results will further lead to expedited regulatory review
• Selumetinib is a MEK 1/2 inhibitor also received the US FDA’s ODD to treat NF1 in Feb 2018 and the European Medicines Agency in Aug 2018. In 2017, AstraZeneca and MSD signed a co-development and co-commercialisation agreement for selumetinib

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