In France, ibrutinib, a drug used to treat certain blood cancers, will receive a temporary cohort authorization for use (ATU) from the National Medicines Safety Agency (ANSM).
Dominique Maraninchi, the director general of the National Medicines Safety Agency (ANSM) told AFP that “the ANSM has decided to give a favorable opinion to the request for temporary authorization for use (ATU) of ibrutinib cohort. “
Ibrutinib is a medicine to treat patients with relapsed or refractory form of the disease.chronic lymphoid eukemia (LLC) as well as a rare form of lymphoma, mantle cell lymphoma (MCL). It is developed by the Janssen-Cilag laboratory.
CLL is the most common leukemia in adults
“With nearly 4,464 new cases in France in 2012, CLL is the most common adult leukemia (30%) “, indicates the Haute Autorité de santé.” Mantle cell lymphoma affects between 600 and 700 new patients each year in France.
“The cohort ATUs will make it possible to make innovative drugs more quickly available to patients”, recalled Mr. Maraninchi. He also specifies that “while waiting for the laboratory to have the product, the ANSM would grant compassionate nominative ATUs to the patients concerned. ”According to the ANSM, several hundred people could benefit from this special authorization.
The Janssen-Cilag laboratory, a subsidiary of Johnson & Johnson, applied for a marketing authorization (MA) for ibrutinib (Imbruvica) last October with the European Medicines Agency (EMA). Last November, ibrutinib received innovative drug status from the US Medicines Agency (FDA) followed by its approval.
Given orally once a day, ibrutinib is the first drug in a class called Bruton’s tyrosine kinase (TKB) inhibitors. If this application is approved in Europe, ibrutinib will be the first treatment available on the market to target TKB.
