From their meeting in July, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for five medicines for approval, which included two new medicines, two orphan medicines and one generic medicine.
A marketing authorisation was recommended for Vitrakvi (larotrectinib), which is the first ‘histology-independent’ treatment in the European Union (EU) for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. A positive opinion was granted by the CHMP for Epidyolex (cannabidiol) for the treatment of seizures associated with two forms of epilepsy; Lennox-Gastaut syndrome or Dravet syndrome. Epidyolex is the first product, which contains an active substance derived from cannabis, to receive a positive opinion in the EU centralised procedure.
The CHMP recommended extensions of indications for eight medicines, including Empliciti, Keytruda, Lucentis and Teccentriq.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.