The European Medicines Agency’s CHMP recommended 12 new medicines for approval and backed multiple label expansions at its September 14–17 meeting, while several applications were withdrawn or moved into re-examination. Among the most notable decisions, the committee supported earlier-line use of Johnson & Johnson’s Tecvayli (teclistamab) in multiple myeloma, broadening eligibility to patients who have received at least one prior therapy.
J&J's Tecvayli:
The teclistamab expansion is supported by data from the MajesTEC-3 trial, which evaluated teclistamab as a monotherapy in patients with multiple myeloma who had received between one and three prior lines of therapy. According to Johnson & Johnson, the drug demonstrated a 71% reduction in the risk of disease progression compared to standard of care. A separate CHMP positive opinion issued in June 2026 had already advanced teclistamab in combination with daratumumab, and the European Commission subsequently approved that combination in August 2026; the current monotherapy expansion now awaits its own EC decision.
Approval recommendations:
Gefurulimab (Klygefa), from Alexion Europe, was recommended for adult patients with generalised myasthenia gravis. Relacorilant (Lifyorli), from Corcept Therapeutics Netherlands B.V., received a positive opinion in combination with nab-paclitaxel. Povorcitinib (Povofortay), from Incyte Biosciences Distribution B.V., was recommended for active moderate to severe disease in its indicated population. Senaparib (Sepalna), from SFL Pharmaceuticals Deutschland GmbH, received a positive opinion as maintenance treatment for advanced disease. Denecimig (Frehemgo), from Novo Nordisk A/S, was recommended for prophylaxis in its indicated population. Ensartinib (Gevalka), also from SFL Pharmaceuticals Deutschland GmbH, was recommended for adult patients in its indicated oncology setting. Glepaglutide (Zeydovio) was recommended for adults with short bowel syndrome and awaits an EC decision.
The meeting also produced positive opinions for biosimilars and generics. Omalizumab biosimilar Adcomfo, from Advanz Pharma Limited, was recommended for asthma and chronic rhinosinusitis with nasal polyps. Pertuzumab biosimilar Pebrilzo, from Biosimilar Collaborations Ireland Limited, was recommended for breast cancer. Generic approvals included tofacitinib (Inijaq) from Gedeon Richter Plc. for rheumatoid arthritis, psoriatic arthritis, and related conditions, and ruxolitinib (Ruxolitinib Zentiva) from Zentiva k.s. for myelofibrosis in adults.
Label expansions:
Among label expansions, the CHMP issued positive opinions for abiraterone acetate (Abiraterone Mylan), delgocitinib (Anzupgo), secukinumab (Cosentyx), trastuzumab deruxtecan (Enhertu), filgotinib (Jyseleca), pembrolizumab (Keytruda), ocrelizumab (Ocrevus), enfortumab vedotin (Padcev), melphalan flufenamide (Pepaxti), somapacitan (Sogroya), and dabigatran etexilate (Pradaxa), all pending EC decisions.
Application withdrawals: