Regulators in Europe have given the green light to Novartis’ Jakavi, making it the first drug in the continent to be approved for myelofibrosis.
The European Commission has given the thumbs-up to Jakavi (ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly in adults with myelofibrosis. The latter is an uncommon, life-threatening blood cancer characterised by bone marrow failure and enlarged spleen; in the European Union, the disease affects about 0.75 out of every 100,000 people annually.
Novartis quoted Claire Harrison of Guy's Hospital in London as saying that the approval of Jakavi "brings an urgently-needed new treatment option with the potential to make a real difference". She added that by targeting the dysregulated JAK pathway, the drug "delivers a rapid and durable benefit that has the potential to become a new standard of care".
Herve Hoppenot, president of Novartis Oncology, said the firm is committed to "the development of innovative treatments for orphan diseases and are furthering research to assess the potential of targeted Jakavi therapy for other malignancies associated with a dysregulated JAK pathway". The drug is also being investigated for the treatment of polycythemia vera.
The drug, licensed from Incyte, was approved in the USA in November last year and is sold there as Jakafi.