FDA grants fast track designation to GEN-1 for advanced ovarian cancer
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The FDA granted fast track designation to GEN-1 for treatment of advanced ovarian cancer, according to the agent’s manufacturer.
GEN-1 (Celsion) is a DNA-mediated interleukin-12 immunotherapy.
“Fast track designation is an important step in developing GEN-1 for advanced ovarian cancer,” Michael H. Tardugno, Celsion’s chairman, president and CEO, said in a company-issued press release. “Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market. ... We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”
The phase 2 OVATION 2 study is evaluating the addition of GEN-1 to standard neoadjuvant chemotherapy for women with newly diagnosed stage III/stage IV ovarian cancer. PFS serves as the primary endpoint.
Results of the phase 1 portion of the trial showed a higher rate of complete tumor resection among women assigned GEN-1 plus neoadjuvant chemotherapy than those assigned chemotherapy alone (88% vs. 50%).
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