BRIEF—Breakthrough Therapy Designation for selumetinib

1 April 2019

AstraZeneca and Merck & Co have been granted Breakthrough Therapy Designation (BTD) for selumetinib, a MEK 1/2 inhibitor the firms are developing as a treatment for certain children with plexiform neurofibromas (PN), a rare and incurable genetic condition.

The decision was granted based on Phase II data from the SPRINT trial, presented at the 2018 American Society of Clinical Oncology (ASCO) annual meeting.

AstraZeneca licensed the therapy from Array BioPharma in 2003, and has been developing it together with Merck following a 2017 agreement.

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