CHMP refuses three medicines: Tacquell, Yartemlea, Xervyteg
- Sponsor
- Netherlands Cancer Institute; Omeros Ireland Limited; MaaT Pharma
- Drug
- Tacquell, Yartemlea, Xervyteg · autologous melanoma tumour infiltrating lymphocytes, narsoplimab, allogeneic faecal microbiota pooled
- Indication
- advanced melanoma; HSCT-TMA; acute graft-versus-host disease
EMA's CHMP issued negative opinions for three applications at its 22-25 June 2026 meeting: Tacquell (autologous TIL therapy for advanced melanoma), Yartemlea (Omeros narsoplimab for HSCT-TMA), and Xervyteg (MaaT Pharma fecal microbiota for acute graft-versus-host disease).
What this means
Europe's medicines regulator issued formal recommendations against approving three new treatments at this week's review meeting. The most US-relevant of the three is narsoplimab (brand Yartemlea), Omeros's drug for a rare and serious blood-vessel complication of bone marrow transplants — Omeros also received a US rejection on the same drug in 2021 and has been working to resubmit. The other two refusals are an experimental melanoma cell therapy and a fecal microbiota product for acute graft-versus-host disease. Applicants may request re-examination within 15 days; the European Commission typically follows the CHMP's recommendation.
From the source
At the 22-25 June 2026 meeting of EMA's Committee for Medicinal Products for Human Use (CHMP), three applications received negative opinions:
Tacquell — autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded. Applicant: Netherlands Cancer Institute. Indication: treatment of advanced melanoma. (Orphan medicine.)
Yartemlea — narsoplimab. Applicant: Omeros Ireland Limited. Indication: treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). (Orphan medicine.) Note: Omeros has a parallel US BLA for narsoplimab in the same indication that received an FDA Complete Response Letter in 2021; the EU refusal echoes ongoing benefit-risk concerns the company has been working to address.
Xervyteg — allogeneic faecal microbiota, pooled. Applicant: MaaT Pharma. Indication: treatment of acute graft-versus-host disease in adults.
2026 year-to-date: 6 negative opinions on new medicines (3 of those at this meeting).
Reproduced from EMA News · view original · public domain or open-licensed government work