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news.The European Commission (EC) has granted marketing approval for Pharmacyclics' Imbruvica (ibrutinib), a first-in-class, oral, once-daily, non-chemotherapy treatment for patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL).
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Imbruvica, which is now approved throughout the 28 European Union (EU) member states, is indicated for CLL patients who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.
The drug is designed to block signals that tell malignant B-cells to multiply and spread uncontrollably.
Pharmacyclics chairman and CEO Bob Duggan said the company is happy that patients with CLL and relapsed or refractory MCL in the EU will have a first-in-class, oral, single-agent, non-chemotherapy treatment option in Imbruvica.
"This approval underscores the compelling safety and efficacy benefits of IMBRUVICA, including statistically significant improvement in overall survival and progression-free survival in CLL and the overall robustness of the data in MCL," Duggan said.
In the US, Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
Following approval, Janssen-Cilag International NV will become the marketing authorization holder in Europe. Janssen will be responsible for marketing Imbruvica in Europe, Middle East, Africa (EMEA) region, as well as the rest of the world, outside of the US.
The approval was based on data from the Phase II trial (PCYC-1104) in MCL, the Phase III RESONATE study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II trial (PCYC-1102) in CLL/SLL.
Image: Janssen will market Imbruvica in Europe, Middle East, Africa (EMEA) region, as well as the rest of the world, outside of the US. Photo: courtesy of PRNewswire.