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
Ref: AstraZeneca | Image: Mint
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com