The European Commission (EC) has expanded the use of Imbruvica (ibrutinib) to cover combinations with Gazyva (obinutuzumab) for previously untreated adults with chronic lymphocytic leukemia (CLL), and with MabThera (rituximab) for adults with Waldenström’s macroglobulinemia (WM).
This decision follows a recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. It was based on the results of two Phase 3 trials:
- The iLLUMINATE study (NCT02264574) is testing a combination of Imbruvica plus Gazyva (by Genentech) vs. the chemotherapy chlorambucil with Gazyva in previously untreated CLL and small lymphocytic lymphoma;
- The iNNOVATE study (NCT02165397) is testing a regimen of Imbruvica and Mabthera – marketed as Rituxan in the U.S.; by Genentech and Biogen — vs. MabThera and a placebo in previously untreated and relapsed or refractory WM, a rare type of non-Hodgkin’s lymphoma.
Both trials showed that Imbruvica led to a greater proportion of patients alive and with no cancer progression (or progression-free survival), although it was associated with more frequent serious adverse side effects.
“The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively,” Alessandra Tedeschi, MD, a co-investigator in both trials and medical director of the Department of Hematology of Niguarda Hospital, in Italy, said in a press release.
“These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers,” Tedeschi added. Similar regimens including Imbruvica already had been approved in the U.S.
Imbruvica is an oral treatment marketed jointly by Janssen and Pharmacyclics, owned by AbbVie. It works by inhibiting Bruton’s tyrosine kinase, an enzyme with an important role in the development and survival of immune B-cells.
In the European Union, Imbruvica is already used to treat select patients with CLL (both as a standalone therapy and in combination with bendamustine and MabThera), mantle cell lymphoma, and WM.
“With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients,” said Craig Tendler, MD, Janssen Research & Development’s vice president, clinical development and global medical affairs for oncology.
Janssen, Tendler said, remains committed to exploring potential combinations of Imbruvica with other medications to treat types of B-cell lymphoma.
