Please login to the form below

Not currently logged in

Imbruvica and Gazyvo approved in first non-chemo CLL use

Further boost for blockbuster leukaemia drug


Blockbuster leukaemia drug Imbruvica has extended its reach again, gaining FDA approval for combination use with Gazyvo in first-line use in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Imbruvica is co-marketed by J&J and AbbVie, the companies announcing full year revenues of $2.61bn and $3.59bn respectively in the recent Q4 results.

The approval is also good news for Roche and its drug Gazyvo (obinutuzumab) which the company is trying to prove as superior next-generation version of MabThera/Rituxan (rituximab) which is now facing biosimilar competition.

The new FDA approval is the first ever non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and represents the tenth FDA approval for Imbruvica since its US launch in November 2013.

"In just a few years, Imbruvica has become an important treatment for chronic lymphocytic leukaemia. Imbruvica as a single agent – and now as a combination with obinutuzumab – provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy," said Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study.

The study showed that after a median follow-up of 31 months, Imbruvica plus obinutuzumab showed a significant improvement in Independent Review Committee (IRC)-evaluated progression-free survival compared with chlorambucil plus obinutuzumab, with a 77% reduction in risk of progression or death.

Patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV) treated with the combination experienced an 85% reduction in risk of progression or death.

These and positive results from others trials mean Imbruvica is likely to see new uptake in several settings - these include the non-elderly population and those patients previously considered candidates for aggressive chemoimmunotherapy.

There have been setbacks in Imbruvica's programme for expansion, however.  Two weeks ago the RESOLVE trial of the drug in combination with chemotherapy agents failed to show superior efficacy against metastatic pancreatic cancer compared to chemo alone.

Article by
Andrew McConaghie

28th January 2019

From: Marketing



Subscribe to our email news alerts

Featured jobs


Add my company
Jet Off with Maloff Protect

Latest intelligence

Environment: where does the pharmaceutical industry stand?
The communication challenge of helping he next generation to be healthier
As the pressure on the health service increases the health of the next generation is vital for everyone. How do we show positive attitudes and change behaviour while future proofing...
Are we losing sight of what the democratisation of healthcare really looks like?
We have a core responsibility as healthcare communicators to consistently drive for better inclusion, engagement and compliance. What does the ‘democratisation of healthcare’ really look like?...