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Kite Pharma has begun a rolling Biologics License Application submission with the US FDA for KTE-C19. This treatment is for patients with B-cell non-Hodgkin lymphoma.
Kite Pharma, Inc. (Nasdaq:KITE) has begun a rolling Biologics License Application submission with the US FDA for KTE-C19. This treatment is for patients with B-cell non-Hodgkin lymphoma.
According to the press release:
“The pivotal ZUMA-1 study supporting this submission enrolled patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), three subtypes of aggressive NHL. The company expects to complete its BLA submission by the end of the first quarter of 2017.”
CEO Arie Belldegrun said the following:
“I am both proud and appreciative of the Kite team and our clinical investigators, who have helped to make this key milestone possible. This is an important first step toward Kite’s biggest goal – bringing to market a potentially life-saving treatment for patients suffering from aggressive NHL.”
Read the full press release here.