LONDON (Reuters) – Europe’s drugs watchdog gave a green light on Friday to Takeda’s Adcetris (brentuximab vedotin) for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, alongside Johnson & Johnson’s Dacogen (decitabine injection) for acute myeloid leukemia.
The European Medicines Agency also backed wider use of Abbott Laboratories’ top-selling Humira (adalimumab) — expected to be the world’s biggest-selling medicine in 2012 — for moderate Crohn’s disease.
Celgene, however, got a negative recommendation for Istodax (romidepsin injection), its treatment for peripheral T-cell lymphoma. The U.S. biotech said it would request a re-examination.
Celgene said regulators acknowledged that the drug, also known as romidepsin, demonstrated anti-tumor activity, and the company said it remains convinced that the drug represents an important new therapy for a disease in which patients have very few options.
The U.S. Food and Drug Administration approved the drug based on the same trial data last year but advisors to the EMA recommended against approval, saying the lack of a comparator arm made it difficult to assess the drug’s relative benefits and risks.
Recommendations for drug approvals by the EMA are normally endorsed by the European Commission within a couple of months.