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