Imbruvica Approved for Waldenström's Macroglobulinemia


Johnson & Johnson's Imbruvica has been approved by the U.S. Food and Drug Administration to treat Waldenström's macroglobulinemia (WM), a rare form of blood cancer. Prior to this indication, no specific pharmaceutical therapy had existed for this condition.

WM is a very rare subtype of non-Hodgkin's lymphoma. It is a progressive disease that causes abnormal B lymphocytes (B-cells) to develop within the bone marrow, lymph nodes, liver and spleen.

Imbruvica, already approved to treat chronic lymphocytic leukemia and mantle cell lymphoma, works by blocking the enzyme that allows abnormal B-cells to develop.

FDA sees Imbruvica as possible breakthrough treatment

The FDA granted Imbruvica breakthrough therapy designation for WM, meaning that the regulatory agency sees the drug as a major advance in the treatment of this diseases.

However, the FDA included in its approval a warning that Imbruvica can cause a potentially fatal condition known as tumor lysis syndrome (TLS).

TLS is the consequence of too many cancer cells being killed too quickly in the body. The rate of cell death is too high for the kidneys to keep up; they can't expel the breakdown products from the blood.

Source: Reuters

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