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Iovance's cervical cancer drug gains US FDA breakthrough therapy status

The U.S. Food and Drug Administration granted a breakthrough therapy status to San Carlos, Calif.-based Iovance Biotherapeutics Inc.'s potential therapy LN-145 to treat a certain type of cancer.

The decision was based on results from an ongoing study, named innovaTIL-04, which is evaluating LN-145 to treat patients with cervical cancer that has spread to other parts of the body or keeps recurring, with disease progression on or after chemotherapy.

"The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review," President and CEO Maria Fardis noted in a May 22 statement.