Special Protocol Assessment (SPA) For Phase III Trial Evaluating Farletuzumab In Relapsed Ovarian Cancer

News — By on April 14, 2009 at 12:46 pm

EXTON, Pa. — Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. Food and Drug Administration (FDA) has agreed to and approved the design of a single, pivotal, Phase III clinical trial evaluating farletuzumab (also known as MORAb-003) in platinum-sensitive ovarian cancer patients experiencing their first relapse. The agreement was made under the Special Protocol Assessment (SPA) procedure. “We are pleased that the FDA has approved the protocol for this Phase III study of farletuzumab in first-relapsed, platinum-sensitive ovarian cancer,” stated Martin D. Phillips, M.D., Chief Medical Officer of Morphotek. “Physicians and patients do not have many good choices for treati…

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