Morphotek, Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. 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.
the details can be read here.
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