By Colin Kellaher
Gilead Sciences Inc. (GILD) on Monday said the U.S. Food and Drug Administration granted priority review to the biologics license application for its Kite unit's KTE-X19 for adults with relapsed or refractory mantle cell lymphoma, a rare form of non-Hodgkin lymphoma.
The Foster City, Calif., biopharmaceutical company said the filing is supported by data from a Phase 2 study in which 93% of patients responded to a single infusion of KTE-X19, including 67% who achieved a complete response.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.
Gilead said the agency set a target action date of Aug. 10 for the application.
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