US-based Pharmacyclics has received marketing approval from the European Commission (EC) for its Imbruvica (ibrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
The approval allows selling of the oral, once-daily and non-chemotherapy treatment in the 28 European Union (EU) member states. It is capable of inhibiting a protein called Bruton’s tyrosine kinase (BTK).
Pharmacyclics CEO Bob Duggan said: "We are very pleased that patients with CLL and relapsed or refractory MCL in the European Union 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."
The approval was granted based on data from the Phase II study (PCYC-1104) in MCL, the Phase III Resonate study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL.
Pharmacyclics, along with Janssen Biotech, has developed and commercialised Imbruvica in the US. Janssen affiliates will sell Imbruvica in Europe, Middle East, Africa (EMEA), and rest of the world outside the US, as they hold the marketing authorisation.
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.
Pharmacyclics noted that accelerated approval was granted for the MCL indication based on overall response rate (ORR).
Image: Nodular mantle cell lymphoma (high power view). Photo: courtesy of Gabriel Caponetti.
