The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended selumetinib for conditional marketing authorisation in the bloc for paediatric patients aged three years and above.
The treatment is for symptomatic, inoperable plexiform neurofibromas, which are tumours that grow from nerves anywhere in the body.
It’s a genetic condition affecting 1 in 3,000 individuals worldwide, potentially causing clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment, and bladder/bowel dysfunction.
The CHMP also recommended for EU approval for cancer drug tagrisso, when used for epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after the tumour has been removed.
The recommendation was based on late-stage trials where the treatment showed statistically significant and clinically meaningful improvement in disease-free survival.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease.
In a third announcement, the FTSE 100 pharma giant said a phase III trial met its primary goal in infants suffering from respiratory syncytial virus (RSV) and treated with nirsevimab.
The analysts observed a statistically significant reduction of lower respiratory tract infections compared to placebo.
Nirsevimab is a long-acting antibody developed by AstraZeneca and Sanofi, with the potential to provide immunity directly to infants and offer immediate protection against RSV.
RSV is a very common, contagious pathogen that causes seasonal epidemics of LRTI, including bronchiolitis and pneumonia. It is the leading cause of hospitalisations in infants worldwide.
Shares were flat at 7,588p on Monday morning.