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.