Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Having completed a special protocol assessment with the FDA, Genta has announced plans to begin a confirmatory trial of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia.
Subscribe to our email newsletter
The special protocol assessment (SPA) documents the FDA’s agreement regarding the trial’s design and planned analyses to fulfill commitments that may be required under provisions relating to accelerated approval.
The trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, will randomize patients to receive fludarabine plus rituximab (Genentech’s Rituxan) with or without Genasense (oblimersen sodium) injection.
Genta has filed a new drug application (NDA) for Genasense plus chemotherapy, which is currently under review by the FDA. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act.
“Data from our previous randomized trials have suggested that extensive prior treatment may introduce other mechanisms of acquired drug resistance,” said Dr Loretta Itri, Genta’s chief medical officer and president of pharmaceutical development. “This study targets treatment-naive patients with a regimen that is still considered investigational, but which includes the most widely prescribed drugs for chronic lymphocytic leukemia (CLL) in the US.”