FDA grants priority review to tumour drug selumetinib

The US Food and Drug Administration (FDA) has awarded priority review status for AstraZeneca and MSD (Merck)’s selumetinib to treat neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) in children. If approved, selumetinib would be the first drug for paediatric patients aged three years and above with NF1 plexiform neurofibromas, said the companies. Selumetinib inhibits the MEK enzyme involved in the RAS/MAPK cell-signalling pathway, which is linked to cancer cell growth and proliferation in a variety of tumour types. AstraZeneca and MSD agreed to jointly develop and commercialise the drug worldwide. The new drug application (NDA) submitted to the FDA is supported by positive data from the SPRINT Phase II Stratum 1 clinical trial, which was funded under the National Cancer Institute (NCI) Cancer Therapy Evaluation Programme (CTEP).