Genta Incorporated has submitted an amendment to the new drug application (NDA) for Genesense® (oblimersen sodium) injection to the United States Food and Drug Administration (FDA). The initial NDA was submitted for Genasense to be used with chemotherapy for the treatment of relapsed or refractory chronic lymphocytic leukemia.
The amendment is based on findings of a Phase III trial that demonstrated a significant improvement in survival for patients who achieved a partial or complete response to Genasense and chemotherapy versus patients treated with chemotherapy alone.
The FDA notified Genta of a decision regarding a regulatory path forward that “included but was not limited to determination of long-term survival in patients who entered the study.” Genta believes that the amendment submitted is in complete agreement with the FDA’s proposal.
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