(Reuters) – Roche, the world’s biggest maker of cancer drugs, said U.S. health regulators granted a priority review to its experimental breast cancer drug TDM-1, expediting the review process for the marketing application of the drug.
The U.S. Food and Drug Administration will announce its decision on the marketing approval by February 26, the Swiss drugmaker said.
The FDA grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.
Roche said its marketing application for the drug was accepted by European regulators.
TDM-1, or trastuzumab emtansine, is being developed with ImmunoGen, using ImmunoGen’s targeted antibody payload delivery technology.
Roche said in late-August that the drug significantly extended the lives of women with an aggressive type of breast cancer, compared with those receiving the standard drug cocktail.
(Reporting By Pallavi Ail in Bangalore; Editing by Maju Samuel)
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FDA grants priority review to Roche’s breast cancer drug
