The FDA's advisory committee for cancer drugs turned thumb's down on Genta's cancer therapy Genasense on Wednesday, voting seven to three to recommend against approval. The news was no surprise and investors bailed before the vote was ever taken, sending shares down 38 percent in advance of the advisory committee meeting. The therapy was intended to treat refractory chronic lymphocytic leukemia, in conjunction with chemotherapy but data from a pivotal trial failed to impress a majority of the committee. In a trial, 17 percent of volunteers responded to the combinational therapy compared to seven percent receiving chemo alone. Genta, though, says it isn't retreating.
"While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer," said Dr. Raymond P. Warrell Jr., Genta's chief executive, in a statement. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application."
- read the AP's report on Genta