By Estel Grace Masangkay
Pharmacyclics reported that its Type II variation application for Imbruvica (ibrutinib) as treatment for Waldenstrom's Macroglobulinemia (WM) has been accepted by the European Medicines Agency (EMA) for review.
Imbruvica is a first-in-class oral therapy that works to inhibit the protein Bruton's tyrosine kinase (BTK), a key signaling molecule crucial in the survival and spread of malignant B cells. The drug is approved for several indications, which include chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Imbruvica recently received approval from Health Canada for the treatment of CLL.
The EU filing was accomplished by its partner Janssen-Cilag, which holds marketing rights for the drug in the EU, Middle East, Africa, and other countries in the world outside the U.S. The companies have also submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in October this year. Both the FDA and EMA filings were supported by data from a mid-stage trial investigating the use of Imbruvica in patients with WM.
Waldenstrom's macroglobulinemia is a slow-growing, rare type of B-cell lymphoma for which no approved treatments exist in the EU at present. The disease is set off by a malignant change to the lymphocyte B cell, which triggers the reproduction of more malignant B cells. WM is predominantly diagnosed in elderly patients aged 63 to 68 years old. The disease affects 7.3 men and 4.2 women per million in the EU.
Dr. Thorsten Graef, VP of Clinical Science at Pharmacyclics, said, “This additional application in the EU shows [that Pharmacyclics and Janssen] pursue the ongoing potential for Imbruvica. If approved, Imbruvica could address a very important unmet need for patients with WM in Europe, who currently have limited treatment options.”
The acceptance of Janssen’s application will lead to a $20 million milestone payment to Pharmacyclics, according to the terms of its collaboration agreement with Janssen Biotech.