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

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

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: Mint

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post