U.S. health regulators on Wednesday approved a drug to treat a rare and aggressive form of non-Hodgkin lymphoma developed by Johnson & Johnson and Pharmacyclics Inc, marking the second drug that received the FDA's new breakthrough therapy designation to gain approval.
The drug, to be sold under the brand name, Imbruvica, and known chemically as ibrutinib, was approved to treat mantle cell lymphoma in patients who have received prior treatment with at least one other medicine, such as Celgene Corp's Revlimid.
Mantle cell lymphoma represents about 6 percent of non-Hodgkin lymphoma cases in the United States and has typically spread to lymph nodes, bone marrow and other organs by the time it is diagnosed, the Food and Drug Administration said.
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