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 allows selling of the oral, once-daily and non-chemotherapy treatment in the 28 European Union (EU) member states."

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.