FDA sets Priority Review Designation for New Cancer Drug Combination


AbbVie, one of the leading pharmaceutical companies in the world, has announced that it has received positive feedback from the Food and Drug Administration for a new combo of drugs that targets blood cancer.

The mixture of Imbruvica (Ibrutinib) plus Rituximab (Rituximab) has shown enough promise to prompt the FDA to direct more attention and resources into the research regarding the effects it has on Waldenström’s Macroglobulinemia (WM), a more rare form of B-cell lymphoma.

Clinical trials showed a great improvement in the survival rates of patients treated with this combination of drugs compared with the usual route of administering Rituximab alone. Over the first 30 months, there was an increase from 28% to 82% and patients displayed a more sustained level of hemoglobin.

The press release echoes more reasons for optimism, highlighting that the Imbruvica and Rituximab combo is the first (and only) FDA-approved treatment for people suffering from WM. Furthermore, this can become the initial step for a chemotherapy-free path, as both drugs are in tablet form.

While the incidence of Waldenström’s Macroglobulinemia (a type of non-Hodgkin’s lymphoma) is quite low, about 2800 case each year in the U.S., the disease is currently incurable and has limited treatment options.

Ibrutinib works by blocking Bruton’s tyrosine kinase protein (BTK), disrupting signals between malignant B cells from spreading and multiplying. It is currently involved in more than 130 ongoing trials relating to other forms of blood and solid tumor cancers.

As with most drug, there are some potential side effects, including: infections, cardiac arrhythmias, hemorrhage etc.

You can find the full information about Imbruvica here.