AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

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

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Investors Chronicle