Pharmaceutical giants AbbVie, Janssen and Genentech have combined their efforts to offer a new therapy course involving a combination of drugs meant to help people suffering from Waldenström’s macroglobulinemia (WM).
The Food and Drug Administration has approved the use of Imbruvica (ibrutinib) and Rituxan (rituximab) combo in the treatment of a rare and incurable type of non-Hodgkin’s lymphoma (NHL) that affects B cells. Patients now have a less taxing alternative to the current standard treatment – chemotherapy.
In a press release, the Head of Clinical Development, Thorsten Graef, M.D., Ph.D. said: “We are pleased to have IMBRUVICA approved, both as a single agent and combination therapy with rituximab, to provide an additional efficacious treatment option for people living with Waldenström’s macroglobulinemia”.
The decision comes as a result of extensive research culminating with a very revealing clinical trial. 150 participants were administered daily oral doses of 420mg Ibrutinib and intravenous Rituximab, 375 mg/m2 in two 4-week cycles.
At 30 months after the initial session, the progression-free survival (PFS) rate for ibrutinib–rituximab was 82% compared to 28% with placebo–rituximab. Significant increases in hemoglobin level were also observed.
The most frequent side effects experienced by patients were: bruises (37%), pain (35%), hemorrhage (32%), diarrhea (28%), rashes (24%), arthralgia (24%), nausea (21%), and hypertension (20%).
Imbruvica blocks a protein called Bruton’s tyrosine kinase (BTK), responsible for the survival and spread of malignant B cells. Rituxan binds to the CD20 antigen of B-cell tumors and then employs the body’s natural defenses to attack and kill them.
According to the presentation abstract, the Imbruvica – Rituxan combination “should be considered a standard therapeutic option for patients with Waldenström’s macroglobulinemia”.