Genta completes response to EMEA's Genasense queries
USA-based Genta has completed its response to the 180-day list of outstanding issues from the European Medicines Agency (EMEA) regarding the Marketing Authorization Application for Genasense (oblimersen sodium), its lead anticancer product, for the treatment of patients with advanced melanoma. The company anticipates that the EMEA's Committee on Human Medicinal Products (CHMP) will complete its review and issue its opinion regarding approval within the next 90 days.
Genasense is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma, the firm noted.
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