'Breakthrough' designation for Merck drug
Merck & Co. said Mondaythe Food and Drug Administration has granted "breakthrough therapy designation" for its Keytruda medicine to treat relapsed classical Hodgkin lymphoma, a blood cancer.
Merck & Co. said Mondaythe Food and Drug Administration has granted "breakthrough therapy designation" for its Keytruda medicine to treat relapsed classical Hodgkin lymphoma, a blood cancer.
The company said the designation, intended to expedite the development and review of drugs that treat serious or life-threatening diseases or conditions, is the fourth "breakthrough therapy" status for Keytruda, a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. The FDA earlier agreed to review the drug for treatment of advanced melanoma, non-small cell lung cancer, and colorectal cancer.
Merck, based in Kenilworth, N.J. employs about 9,200 in West Point and Upper Gwynedd in Montgomery County.
The FDA gives a drug "breakthrough" status when preliminary clinical evidence indicates that the medicine may demonstrate substantial improvement over existing therapies. Once a drug is designated as breakthrough therapy, the FDA will expedite the development and review of that drug.
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