Kite, a Gilead Company (GILD), announced the FDA approved an update to the Yescarta prescribing information removing the previous Limitations of Use in patients with relapsed or refractory primary central nervous system lymphoma. The FDA decision is based on positive results from a Phase 1 investigator-sponsored study.
Gallia Levy, Senior Vice President and Global Head of Development, Kite, said: "We appreciate the FDA's timely review and decision, which expands access to Yescarta for patients with primary central nervous system lymphoma-one of the most aggressive and underserved forms of the disease-and we are deeply grateful to the patients and clinicians who made this progress possible."
In pre-market trading on NasdaqGS, Gilead shares are up 0.35 percent to $149.90.
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