Shots:

• The US FDA has accepted NDA and granted Priority Review for Selumetinib as a new therapy for pediatric patients aged ≥3yrs. with neurofibromatosis type 1 (NF1) and symptomatic- inoperable plexiform neurofibromas (PNs)
• The NDA submission is based on SPRINT P-II Stratum 1 study evaluating Selumetinib (bid- PO) in pediatric patients with NF1 and symptomatic- inoperable PNs demonstrated 66% ORR which is defined as the percentage of patients with a confirmed complete or partial response of ≥ 20% tumor volume reduction
• Selumetinib is a MEK 1/2 inhibitor- act by inhibiting MEK enzyme in the RAS/MAPK pathway which is associated with the growth & proliferation of cancer cells in multiple tumor types

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