The early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states.
Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
This likely new cancer blockbuster is marketed as the trade name Imbruvica, and is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. (Janssen). Janssen affiliates will sell Imbruvica in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S. In addition to EU markets, a worldwide regulatory filing program for ibrutinib is currently underway.
In the US, Imbruvica obtained approval to treat patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p), including treatment-naive and previously treated del 17p CLL patients.
The EC approval was based on data from the Phase 2 study (PCYC-1104) in MCL, the Phase 3 RESONATE™ study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL. This approval is based on the Imbruvica Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) last year.
In 2013 the NDA for Ibrutinib was placed on a priority basis by the FDA after a Phase 2 multicenter study of Ibrutinib was presented, and it identified a staggering 70% response rate from MCL patients with 68% of patients demonstrating an overall response rate after roughly nine months.
In June 2014, study results revealed Ibrutinib elicited a significant improvement for patients with either CLL or SLL in both overall survival and progression free survival in a study comparing it with Ofatumumab.
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