AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

April 26, 2021 Auto Bot AstraZeneca, CHMP, EU, First, MSD, Positive Opinion, Receive, regulatory, therapy 0

Shots:

  • EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum 1 trial evaluating selumetinib as a monothx (PO, bid) in pediatric patients aged ≥3yrs. with NF1 and symptomatic, inoperable PNs
  • The trial showed 66% ORR which is defined as the percentage of patients with a confirmed complete or partial response of atleast 20% tumor volume reduction
  • Selumetinib is a MEK1/2 inhibitor. The clinical trials of selumetinib in adult patients with NF1 PN, and in an alternative age-appropriate formulation for pediatric patients, are expected to be initiated in 2021

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Business Standard

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