The European Medicines Agency released its monthly update on approval recommendations from the Committee for Medicinal Products for Human Use (CHMP), with five new medicines given the nod. Those five span oncology, rare diseases, and specialty care.
The five recommendations were: Adstiladrin (nadofaragene firadenovec) from Ferring Pharmaceuticals, a gene therapy delivering interferon alfa-2b via a non-replicating adenoviral vector for Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder cancer. Amgen’s Imdylltra (tarlatamab), a bispecific T-cell engager targeting DLL3 on tumor cells and CD3 on T cells for relapsed extensive-stage small cell lung cancer.
The committee also recommended Ziihera (zanidatamab) from Zymeworks, a HER2-targeting bispecific antibody binding two distinct epitopes for previously treated HER2-positive biliary tract cancer, and Tryngolza (olezarsen) from Ionis Pharmaceuticals, an antisense oligonucleotide targeting APOC3 to reduce triglyceride levels in familial chylomicronaemia syndrome.
The fifth recommendation was Vimkunya, a chikungunya vaccine developed by Valneva, designed to induce neutralizing antibodies against the chikungunya virus for prevention of infection in adults.
The set of opinions highlights a mix of advanced therapies, oncology agents, and paediatric formulations progressing through the EU regulatory pathway, with CHMP opinions now set to be reviewed by the European Commission for final approval.